Systems and methods for use in treating sensory impairment

ABSTRACT

Methods and systems for use in treating one or more patient’s sensory impairment, e.g., associated with peripheral neuropathy. An exemplary system may be configured to generate treatment information for treating sensory impairment in at least one body portion using photonic energy from a therapeutic laser based on data indicative of damage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional ApplicationSerial No. 61/469,084 filed 29 Mar. 2011, entitled “Systems and Methodsfor use in Treating Sensory Impairment” and U.S. Provisional ApplicationSerial No. 61/550,556 filed 24 Oct. 2011, entitled “Systems and Methodsfor use in Treating Sensory Impairment,” each of which are incorporatedherein by reference in their entirety.

BACKGROUND

Sensory impairment, whether acute, transient, and/or chronic (e.g.,pain, soreness, tingling, burning, numbness, altered proprioception,stiffness, sharp, etc.) in a patient’s extremities can be associatedwith a number of conditions and result from a number of causes includingboth mechanical, biological, and chemical insult(s). One very commoncondition is peripheral neuropathy (e.g., diabetic neuropathy,neuropathy associated with chemotherapy, etc.). Peripheral neuropathymay occur when the nerves connecting an individual’s spinal cord andbrain to other parts of the body (peripheral nerves) become damagedand/or nerve transmission is interrupted. Damage/disruption to theperipheral nerves may cause symptoms such as, for example, tingling andnumbness, lack of sensation, pain, balance and coordination impairment,diminished hot and cold sensation, hypersensitivity to hot and cold,phantom hot and cold sensations, muscle weakness, etc. that may mostcommonly begin in the hands or feet and may spread throughout theextremities, or that may, e.g., begin in the torso and spread throughoutthe torso and/or abdomen.

The nerve damage of peripheral neuropathy most commonly appears as acomplication of another disorder such as diabetes or AIDS, or as areaction to drugs, alcohol, or various chemicals (including sometherapeutics such as chemotherapeutics). A large portion of peripheralneuropathy presentations, e.g., roughly 30%, are considered idiopathic,or of unknown origin, and can exist seemingly without causal pathology.Nerve damage can also result from viral and bacterial infections,rheumatoid arthritis, lupus, autoimmune disorders, exposure to toxins,cancer and/or cancer treatments, vitamin deficiencies, kidney disease,liver disease, or inherited/hereditary conditions. Other causes ofperipheral neuropathy include trauma, penetrating or crush injuries,bruises, fractures, and dislocated bones. Nerve damage can also bepresent in situations lacking clear causal pathology that is diagnosedsecondary to one or more other diseases. Nerve damage can also resultfrom extended exposure to cold or heat, radiation and/or chemicaltherapy for cancer, excessive vomiting (which may occur during earlypregnancy), and various other causes.

Exposure to toxic chemicals can cause neuropathy. Toxic chemicals thatcan cause neuropathy may include industrial agents such as, e.g.,solvents, heavy metals such as lead, arsenic, mercury, pesticides,nitrous oxide, etc. Sniffing glue or other toxic compounds can alsocause peripheral neuropathy. Likewise, nutritional deficiencies maycause peripheral neuropathy. Alcoholism may also be a cause ofneuropathy. Further, roughly 33% of the total cases of peripheralneuropathy in the United States are related to diabetes whileapproximately 30% are idiopathic.

When a peripheral nerve is damaged, communication between the centralnervous system and the area of the body served by the peripheral nerveis disrupted. The type of damage to the nerves influences the types ofsymptoms that may occur. For example, if the sensory nerve fibers aredamaged, the patient will likely experience changes in sensation such asnumbness or pain, either at the site of nerve damage, distant thereto,or both. In addition, pain perception may vary from one patient toanother. For example, one may experience broad regions of numbness,others an aching sensation, and still others areas of both sharp and/orpenetrating discomfort with surrounding areas of sensory disruption.These and other symptoms may occur alone and/or in various combinationsthat vary with time of day, season, activity, and variable externalfactors including, e.g., heat, cold, humidity, and/or barometricpressure. However, if the motor fibers are damaged, muscles may beaffected, e.g., causing changes in the ability to move and/or balanceproperly. Reductions in the ability to move can diminish the range ofmotion in the affected areas. For example, the reductions in the abilityto move, or alternations in motor function, can change gait and stance,and may contribute to, or be contributing factors for, lower back pain.Further, for example, intrinsic foot muscles can become weakened therebypredisposing one to mechanical foot pain or plantar fasciitis as thefoot pronates upon weight bearing, which can also lead to mechanicaland/or structural issues. These reductions in range of motion can alsolead to what is called soft tissue contracture. This “shrinking” of theconnective tissues, such as tendons and joint capsules, can furtherlimit mobility. These soft tissue contractures by themselves can becomepainful and lead to a burning sensation called facial pain. Motorfunction problems can also lead to problems with balance andcoordination. Thus, peripheral neuropathy can become a safety issue, forexample, when a person can no longer feel how hard they are pushing onthe gas or brake pedal, or even on which pedal their foot rests.

Patient afflicted with peripheral neuropathy may experience burningand/or freezing sensations, shooting pain (e.g., which may be worse atnight), gradual muscular weakening, skin that is extremely sensitive totouch, and loss of balance or coordination. In extreme cases, suchpatients may lose the ability to stand, walk, or hold objects.Peripheral neuropathy can also affect the nerves that control automaticfunctions such as heartbeat, bladder control, or bowel function.Patients may experience diarrhea or constipation, incontinence, sexualimpotence, and high or low blood pressure. Further, the patients’ skinmay become dry and pale, and patients may sweat excessively and may alsodevelop blurred vision, dizziness or fainting spells, or stomach andintestinal problems.

Not uncommonly, the nerve damage and numbness of peripheral neuropathycan lead to injuries and infections. Because sensation is limited withneuropathy, patients may be unaware of an injury such as a burn or a cutor even mild or severe external physical insult. The untreated wound orbruise may then become infected or may result in secondary issues suchas clots and their sequelae. This may be common in diabetic patients whooften develop neuropathy in their feet, and then develop painless cutsthat can become infected. Balance and coordination may also be alsoaffected, and thus, falling is a concern.

Various treatment options have been identified for peripheral neuropathywith a goal of managing the underlying causal condition, such as, in thecase of diabetic neuropathy, controlling blood sugars. More often,however, the goal of treatment is the management of symptoms, such asthe medications intended to mitigate pain. These approaches address thesymptoms of peripheral neuropathy, not the nerve damage itself. Evenwhen the underlying cause is identified and treated, the damage to thenerves, and the resulting pain, numbness, tingling, and other symptoms,must still be treated independent of the causal condition. There islittle in the literature regarding treatments that improve touchsensation. Further, while many conventional treatment options attempt toaddress the symptoms related to nerve damage, the actual nerve damagerelated to peripheral neuropathy may still progress independent of theinitial cause or triggering condition. For example, treatments for acutenerve pain may progress to transient and/or chronic pain. Further,chemotherapy and other therapeutic modalities may damage either or bothnerves and muscles, and that damage may result in peripheral neuropathy,which may progress independent of the continuation or termination ofchemotherapy. In addition, nerve pain and/or dysfunction may causemuscle damage and/or spasms that, in turn, may further exacerbateunderlying peripheral neuropathy.

Pharmacologic pain management (e.g., a common approach) may be in theform of, e.g, anticonvulsants, analgesics, opioids, anti-seizuremedications, topical preparations and antidepressants Some agents thathave been used in symptomatic management include Pregabalin (LYRICA),Gabapentic (NEURONTIN), Oxacarbazine (TRILEPTAL), Topiramate (TOPOMAX),Lamotrigine (LAMICTAL), Duloxetine (CYMBALTA), Amitriptyline (ELAVIL),Nortriptyline (PAMELOR), Venlafaxine (EFFEXOR), Oxycodone CR(OXYCONTIN), Fentanyl (DURAGESIS TRANSDERMAL SYSTEMS), Methadone(DOLOPHINE), Lidocaine patches, and/or Capsaicin (ZOSTRIX).Unfortunately, these have significant, and undesirable, side effects.Additionally, as the body adjusts to these drugs over time, theireffectiveness may diminish. Dosages are typically increased to providesome continuing relief. Ultimately, however, these therapeutic protocolsoften become ineffective. Given the lack of success of the conventionalcare approaches, patients with peripheral neuropathy may ultimatelyeither live with the pain, numbness and tingling of early stageperipheral neuropathy, the motor control issues of later stageperipheral neuropathy, or live with the considerable side effects ofdrug treatments whose effectiveness may dissipate over time.

In addition, hyperalgesia (e.g., an increased sensitivity to pain) maybe caused by long term (eg., greater than three months) use of some painmanagement drugs. Further, hyperalgesia may be caused by damage tonociceptors and/or peripheral nerves, although the mechanism has notbeen definitively identified. Further, use of masking agents such asopioids may actually extend or exacerbate peripheral neuropathy due tofailure to engage in physical activity resulting in degenerativedisorders including muscle atrophy, depression, and withdrawal fromday-to-day activities. Other alternative treatments have also beenidentified, including acupuncture, topical application of capsaicincream, ingestion of alpha-lipoic acid and vitamin supplements,biofeedback, physical therapy, including exercise, massage, and theapplication of heat These alternative treatments have seen limitedsuccess. Other alternative treatments may include ultrasound, “coldlaser” (low-power Class III), and LED-arrays. Results with these otheralternatives treatments thus far, however, have been unimpressive andbrought unremarkable patient relief.

SUMMARY

A reduction of sensory impairment (e.g., pain, soreness, tingling,burning, numbness, stiffness) in a patient’s body portion (e.g., anextremity such as a leg, an arm, a foot, a hand, buttocks, etc.)associated with, e.g., peripheral neuropathy, may be treated with theuse of therapeutic lasers, particularly Class IV therapeutic lasers. Ithas been discovered that therapeutic lasers, particularly Class IVtherapeutic lasers, can be used effectively and consistently in themethods and systems described herein for reduction of sensory and/orvascular impairment.

One exemplary embodiment of a method of reducing sensory impairment in asubject’s extremity includes exposing selected tissue in proximity to aselected nerve root to photonic energy from a therapeutic laserapparatus at a power of at least 6.5 Watts and exposing selected tissueof an affected extremity in proximity to a nerve extending from theselected nerve root to photonic energy from a therapeutic laserapparatus at a power of at least 5.5 Watts.

In one or more embodiments of the exemplary method, the method mayinclude one or more of the following: exposing selected tissue inproximity to a selected nerve root to photonic energy occurs for atleast 1 minute; exposing selected tissue in proximity to a selectednerve root to photonic energy occurs for no greater than 105 minutes;exposing selected tissue of an affected extremity in proximity to anerve extending from the selected nerve root to photonic energy occursfor at least 5 minutes; exposing selected tissue of an affectedextremity in proximity to a nerve extending from the selected nerve rootto photonic energy occurs for no greater than 20 minutes; exposing theselected tissue for a period of time sufficient to deliver a totaldosage of at least 7000 Joules to the selected tissue; and exposing theselected tissue for a period of time sufficient to deliver a totaldosage of at least 9000 Joules to the selected tissue.

Further, in one or more embodiments of the exemplary method, theexposing steps may occur in a first treatment in a series of treatmentsoccurring over a period of days or weeks. For example, the subsequenttreatments may include exposing the selected tissue in proximity to theselected nerve root to photonic energy from a therapeutic laserapparatus at a power of at least 6.5 Watts, the subsequent treatmentsmay include exposing the selected tissue of an affected extremity inproximity to a nerve extending from the selected nerve root to photonicenergy from a therapeutic laser apparatus at a power of at least 5.5Watts; the subsequent treatments may include exposing the selectedtissue in proximity to the selected nerve root to photonic energy from atherapeutic laser apparatus at a power of less than 6.5 Watts; and/orthe subsequent treatments may include exposing the selected tissue of anaffected extremity in proximity to a nerve extending from the selectednerve root to photonic energy from a therapeutic laser apparatus at apower of less than 5.5 Watts.

Further, in one or more embodiments of the method, exposing selectedtissue in proximity to a selected nerve root to photonic energy from aClass IV therapeutic laser apparatus at a power of at least 6.5 Wattsmay occur before exposing selected tissue of an affected extremity inproximity to a nerve extending from the selected nerve root to photonicenergy from a therapeutic laser apparatus at a power of at least 5.5Watts.

Further, in one or more embodiments of the exemplary method, exposingselected tissue may occur bilaterally; the sensory impairment may beassociated with peripheral neuropathy; and/or the therapeutic laser maybe a Class IV therapeutic laser apparatus.

Another exemplary method of reducing sensory impairment in a subject’sextremity may include evaluating the sensory impairment; identifying oneor more nerves and nerve roots that are associated with, or suspected ofbeing associated with, the sensory impairment; exposing selected tissuein proximity to the one or more nerve roots to photonic energy from atherapeutic laser apparatus at a power of at least 6.5 Watts for atleast 1 minute; and exposing selected tissue of an affected extremity inproximity to the one or more nerves extending from the selected nerveroots to photonic energy from a therapeutic laser apparatus at a powerof at least 5.5 Watts for at least 1 minute (e.g., wherein the exposingsteps provide at least 7000 Joules of total energy to the subject).

Still another exemplary method of reducing sensory impairment in asubject’s extremity may include evaluating the sensory impairment;identifying one or more nerves and nerve roots that are associated with,or suspected of being associated with, the sensory impairment; exposingselected tissue in proximity to the one or more nerve roots to photonicenergy from a therapeutic laser apparatus at a power of at least 6.5Watts for at least 1 minute; and exposing selected tissue of an affectedextremity in proximity to the one or more nerves extending from theselected nerve roots to photonic energy from a therapeutic laserapparatus at a power of at least 5.5 Watts for at least 1 minute (e.g.,wherein the exposing steps in a first treatment provide at least 7000Joules of total energy to the subject). The method may further includerepeating the exposing steps in one or more subsequent treatments untilat least one symptom of the sensory impairment is reduced.

One embodiment of a computer-implemented method for use in treatingsensory impairment in one or more body portions of a patient may includeproviding data indicative of damage at different damage regions of atleast one body portion of the one or more body portions and generating,using a computer processor, treatment information for treating sensoryimpairment in the at least one body portion using photonic energy basedon the data indicative of damage.

One embodiment of a computer program for use in conjunction with acomputer processor to generate treatment information for one or morebody portions of a patient may be operable when used with the computerprocessor to receive data indicative of damage at different damageregions of at least one body portion of the one or more body portionsand generate, using a computer processor, treatment information fortreating at least one of sensory impairment and vascular impairment inthe at least one body portion using photonic energy from a therapeuticlaser based on the data indicative of damage.

In one or more embodiments of the exemplary computer-implemented methodor computer program, the treatment information may include at least onetreatment definition. The at least one treatment definition may includeone or more treatment regions of the patient to be exposed to photonicenergy to treat the at least one body portion and/or a time period ofexposure to photonic energy for each of the one or more treatmentregions.

Further, in one or more embodiments of the exemplarycomputer-implemented method or computer program, providing dataindicative of damage may include collecting subjective data from thepatient indicative of damage at different damage regions of the at leastone body portion and/or providing data indicative of damage may includeperforming objective testing on the at least one body portion resultingin objective measurement data indicative of damage at different damageregions of the at least one body portion. In at least one embodiment,the method or computer program may further include collecting subjectivedata indicative of restoration symptoms at the different damage regionsof the at least one body portion of the one or more body portions.

Still further, in one or more embodiments of the exemplarycomputer-implemented method or computer program, the one or more bodyportions may include one or more extremities of the patient, andproviding data indicative of damage may include collecting dataindicative of damage at different damage regions of at least oneextremity of the one or more extremities (e.g., the different damageregions of the at least one extremity may be consecutively located alongthe at least one extremity from the patient’s torso to a distal end ofthe at least one extremity). Further, generating treatment informationin such an exemplary method may include generating, using a computerprocessor, treatment information for treating sensory impairment in theat least one extremity using photonic energy based on the dataindicative of damage. In at least one embodiment, the method or computerprogram may include generating, using a computer processor, treatmentinformation for treating the restoration symptoms based on thesubjective data indicative of restoration symptoms.

Yet further, in one or more embodiments of the exemplarycomputer-implemented method or computer program, the method or computerprogram may further include: controlling, using a computer processor,delivery of photonic energy to the patient to treat the at least onebody portion based on the treatment information; generating treatmentinformation may include generating a treatment plan (e.g, a treatmentplan that is generated by determining a number of photonic energytreatments based on the data indicative of damage and determining a timeperiod per photonic energy treatment based on the data indicative ofdamage); and/or providing data indicative of damage may includeproviding data acquired during one or more previous treatments of the atleast one body portion Still further, in one or more embodiments of theexemplary computer-implemented method or computer program, the method orcomputer program may further include displaying treatment information toa therapist delivering photonic energy using a therapeutic laser.

Another exemplary computer-implemented method for use in treatingsensory impairment in one or more body portions of a patient may includeproviding data indicative of damage at different damage regions of atleast one body portion of the one or more body portions (e.g.,collecting subjective data from the patient indicative of damage atdifferent damage regions of the at least one body portion, performingobjective testing on the at least one body portion resulting inobjective measurement data indicative of damage at different damageregions of the at least one body portion, providing data acquired duringone or more previous treatments of the at least one body portion, etc.).The exemplary method may further include generating, using a computerprocessor, treatment information for treating sensory impairment in theat least one body portion using photonic energy from a therapeutic laserbased on the data indicative of damage and controlling, using a computerprocessor, delivery of photonic energy to the patient to treat the atleast one body portion based on the treatment information. In at leastone embodiment, the exemplary methods and systems described herein mayfurther include obtaining approval of the treatment information from apractitioner prior to delivering photonic energy.

In one or more embodiments of the exemplary methods and systemsdescribed herein, the treatment information may include at least onetreatment definition and the at least one treatment definition mayinclude one or more treatment regions of the patient to be exposed tophotonic energy to treat the at least one body portion. Further, the atleast one treatment definition may further include a time period ofexposure to photonic energy for each of the one or more treatmentregions. Still further, the treatment information may include at leastone treatment definition and the at least one treatment definition mayinclude a treatment power of the photonic energy for the at least onebody portion.

In one or more embodiments of the exemplary methods and systemsdescribed herein, the one or more body portions may include one or moreextremities of the patient and providing data indicative of damage mayinclude collecting data indicative of damage at different damage regionsof at least one extremity of the one or more extremities Further, thedifferent damage regions of the at least one extremity may beconsecutively located along the at least one extremity from thepatient’s torso to a distal end of the at least one extremity. Stillfurther, generating treatment information may include generating, usinga computer processor, treatment information for treating sensoryimpairment in the at least one extremity using photonic energy based onthe data indicative of damage. In one or more embodiments of theexemplary methods herein, the exemplary methods may further includedisplaying treatment information to a therapist delivering photonicenergy using a therapeutic laser.

An exemplary treatment system for use in treating sensory impairment inone or more body portions of a patient may include a local system and atherapy system. The local system may include a computer processor andmay be configured to receive data indicative of damage at differentdamage regions of at least one body portion of the one or more bodyportions The local system may be further configured to generatetreatment information for treating sensory impairment in the at leastone body portion using photonic energy based on the data indicative ofdamage. The therapy system may be operatively coupled to the localsystem and may include a therapeutic laser apparatus configured todeliver photonic energy to the patient to treat the at least one bodyportion. The therapy system may be configured to receive the treatmentinformation from the local system for use in performing sensoryimpairment treatment (e.g., to control delivery of photonic energy fromthe therapeutic laser apparatus to the patient based on the treatmentinformation, to display the treatment information to a therapistdelivering photonic energy using the therapeutic laser treatmentapparatus, etc.)

In one or more embodiments of exemplary systems described herein, thelocal system may be further configured to generate treatment informationfor treating sensory impairment in at least one extremity using photonicenergy from the therapeutic laser treatment apparatus based on the dataindicative of damage at different damage regions of the at least oneextremity.

Further, in one or more embodiments of exemplary systems describedherein, the local system may be further configured to obtain approval ofthe treatment information from a practitioner before allowing deliveryof photonic energy from the therapeutic laser treatment apparatus to thepatient based on the treatment information. Still further, in one ormore embodiments of exemplary systems described herein, the treatmentsystem may further include a practitioner system operatively coupled tothe local system and configured to receive the treatment informationfrom the local system. The practitioner system may include a displayapparatus configured to display the treatment information and to prompta practitioner to approve the treatment information, and an inputinterface configured to receive input (e.g., approval of the treatmentinformation) from the practitioner. The practitioner system may befurther configured to transmit the approval of the treatment informationto the local system and/or to allow the practitioner to modify thetreatment information using the input interface. Further, the inputinterface of the practitioner system may be further configured to allowthe practitioner to input data indicative of damage at different damageregions of the at least one body portion based on objective testing onthe at least one body portion of the one or body portions.

And still further, in one or more embodiments of exemplary systemsdescribed herein, the therapy system may include an input interfaceconfigured to receive input from a therapist and the input may includedata indicative of damage at different damage regions of the at leastone body portion of the one or more body portions. Further, the therapysystem may include a display apparatus configured to display thetreatment information, and the treatment information may include atleast one treatment definition (eg., the at least one treatmentdefinition may include one or more treatment regions of the patient tobe exposed to photonic energy to treat the at least one body portionand/or a time period of exposure to photonic energy for each of the oneor more treatment regions). Still further, the therapy system may beconfigured to control delivery of photonic energy by controlling atreatment power of the photonic energy to be delivered for each of oneor more treatment regions based on the at least one treatmentdefinition.

Yet still further, the treatment system may further include a patientinput system. The patient input system may include an input interfaceconfigured to receive input from the patient and the input may includedata indicative of damage at different damage regions of the at leastone body portion of the one or more body portions.

Another exemplary computer-implemented method of providing an interfacefor use in treating sensory impairment in one or more body portions of apatient may include providing a graphical user interface depicting oneor more body portions of a patient (e.g., one or more extremities) andidentifying different damage regions on each of the one or more bodyportions (e.g., the different damage regions may be consecutivelylocated along the one or more extremities from the patient’s torso to adistal end of the one or more extremities). The exemplary method mayfurther include providing an input interface configured to allow a user(e.g., patient, therapist, practitioner, etc.) to input data indicativeof damage of the different damage regions of each of the one or morebody portions of the patient. The exemplary method may further includegenerating, using a computer processor, treatment information fortreating sensory impairment in the one or more body portions usingphotonic energy based on the data indicative of damage.

In one or more exemplary methods described herein, providing an inputinterface configured to allow a user to input data indicative of damagemay include allowing the user to input at least one sensation of aplurality of sensations (e.g, at least one of pain, tingling, numbness,burning, tightness, soreness, etc.) and at least one value for the atleast one sensation for each different damage region of the one or morebody portions

Another exemplary computer system for use in treating sensory impairmentin one or more body portions of a patient may include a displayapparatus configured to display a graphical user interface. Thegraphical user interface may be configured to depict one or more bodyportions of a patient (e.g., one or more extremities) and identifydifferent damage regions on each of the one or more body portions (e.g,the different damage regions may be consecutively located along the oneor more extremities from the patient’s torso to a distal end of the oneor more extremities). The exemplary system may further include an inputinterface configured to allow a user to input data indicative of damageof the different damage regions of each of the one or more body portionsof the patient. The exemplary system may further include a computerprocessor operatively coupled to the display apparatus and the inputinterface The computer processor may be configured to generate treatmentinformation for treating sensory impairment in the one or more bodyportions using photonic energy based on the data indicative of damage.

In one or more exemplary systems described herein, the input interfacemay be further configured to allow the user to input at least onesensation of a plurality of sensations (e.g., at least one of pain,tingling, numbness, heat, burning, tightness, soreness, etc.) and atleast one value for the at least one sensation for each different damageregion of the one or more body portions. In one or more exemplarymethods and systems described herein, the time period of exposure formore distal regions of the one or more treatment regions may be greaterthan less distal regions of the one or more treatment regions if thedata indicative of damage indicates that sensory impairment has beenreduced proximally.

An exemplary method of reducing vascular impairment in a subject’sextremity may include exposing selected tissue in proximity to aselected nerve root to photonic energy from a therapeutic laserapparatus (e.g., at a power of at least 6.5 Watts) and exposing selectedtissue of an affected extremity in proximity to a nerve extending fromthe selected nerve root to photonic energy from a therapeutic laserapparatus (e.g., at a power of at least 5.5 Watts).

An exemplary computer-implemented method for use in treating vascularimpairment in one or more body portions of a patient may includeproviding data indicative of damage at different damage regions of atleast one body portion of the one or more body portions and generating,using a computer processor, treatment information for treating vascularimpairment in the at least one body portion using photonic energy basedon the data indicative of damage.

A “patient” herein includes humans or other mammals that are subject tosensory impairment (e.g., pain, soreness, tingling, burning, numbness,stiffness, etc.) in its one or more body portions (e.g., an extremitysuch as a leg, an arm, a foot, a hand, buttocks, etc.) associated, forexample, with peripheral neuropathy. Other mammals may include, forexample, nonhuman primates, horses, cattle, pigs, sheep, dogs, cats,etc. Preferably, the patient is a human.

The “peripheral nervous system” (PNS) includes of all parts of thenervous system, except the brain and spinal cord, which are thecomponents of the central nervous system (CNS). The peripheral nervoussystem connects the central nervous system to the remainder of the body,and is the conduit through which neural signals are transmitted to andfrom the central nervous system.

Within the peripheral nervous system, sensory neurons transmit impulsesto the CNS from sensory receptors. A system of motor neurons transmitsneural signals from the CNS to effectors (glands, organs, and/ormuscles). The peripheral nervous system is composed of nerve fibers thatprovide the cellular pathways for the various signals on which theproper operation of the nervous system relies. There are two types ofneurons operating in the PNS. The first is the sensory neurons that runfrom the myriad of sensory receptors throughout the body. Sensoryreceptors provide the connection between the stimulus such as touch,heat, cold, and pain and the CNS. As well, the PNS also includes motorneurons. These neurons connect the CNS to various muscles and glandsthroughout the body. These muscles and glands are also known aseffectors, meaning they are the places where the responses to thestimuli are translated into action.

The peripheral nervous system is subdivided into two subsystems: thesensory-somatic nervous system and the autonomic nervous system. Thesensory-somatic nervous system is the sensory gateway between theenvironment outside of the body and the central nervous system.Responses tend to be conscious. The sensory nervous system includestwelve pairs of cranial nerves and thirty-one pairs of spinal nerves.Some of these cranial nerve pairs are exclusively sensory neurons suchas the pairs involved in smell, vision, hearing, and balance. Otherpairs are strictly made up of motor neurons, such as those involved inthe movement of the eyeballs, swallowing, and movement of the head andshoulders. Still other pairs include a sensory and a motor neuronworking in tandem such as those involved in taste and other aspects ofswallowing. All thirty-one of the spinal neuron pairs are mixed: theycontain both sensory and motor neurons. This allows the spinal neuronsto properly function as the conduit of transmission of the signals ofthe stimuli and the subsequent response.

The autonomic nervous system (ANS) includes three subsystems: thesympathetic nervous system, the parasympathetic nervous system, and theenteric nervous system. The ANS regulates the activities of cardiacmuscle, smooth muscle, endocrine glands, and exocrine glands. The ANSfunctions involuntarily (e.g., reflexively) in an automatic mannerwithout conscious control. The ANS achieves this control via twodivisions of the ANS, the sympathetic nervous system and theparasympathetic nervous system. These systems can act to stimulateorgans and tissues in opposite ways (antagonistically). For example,parasympathetic stimulation acts to decrease heart rate. In contrast,sympathetic stimulation results in an increased heart rate. Theautonomic nervous system also differs from the somatic nervous system inthe types of tissue innervated and controlled. The somatic nervoussystem regulates skeletal muscle tissue, while the ANS services smoothmuscle, cardiac muscle, and glandular tissue.

The nerve fibers of the sympathetic system innervate smooth muscle,cardiac muscle, and glandular tissue. In general, stimulation viasympathetic fibers increases activity and metabolic rate. Accordingly,sympathetic system stimulation is a critical component of the fight orflight response. Parasympathetic fibers of the parasympathetic nervoussystem innervate smooth muscle, cardiac muscle, and glandular tissue. Ingeneral, stimulation via parasympathetic fibers slows activity andresults in a lowering of metabolic rate and a concordant conservation ofenergy. Accordingly, the parasympathetic nervous sub-system operates toreturn the body to its normal levels of function following the suddenalteration by the sympathetic nervous subsystem—the so-called “rest anddigest” state. Examples may include the restoration of restingheartbeat, blood pressure, pupil diameter, and flow of blood to theskin. For a graphical representation of the sympathetic andparasympathetic nervous systems, please seehttp://images.encyclopedia.com/utility/image.aspx?id=2799137&imagetype=Manual.

The enteric nervous system is made up of nerve fibers that supply theviscera of the body: the gastrointestinal tract, pancreas, andgallbladder.

More information about the peripheral nervous system can be found inHoyle, Brian; Arthur, Paul. “Peripheral Nervous System.” GaleEncyclopedia of Neurological Disorders. 2005(http://www.encyclopedia.com); andhttp://www.vivo.colostate.edu/hbooks/pathphys/digestion/basics/gi_nervous.html.

Herein, it is possible to find a non-dermatomal pattern of sensoryimpairment, e.g., from the toes to the ankles, as well as a dermatomalpattern, e.g., the lateral side of the leg, overlying the pathway alongwhich a nerve runs between the central axis (e.g., the spinal cord) anda distal innervation site (e.g., the hand and/or foot). This suggestsaxonopathy in addition to a problem along the path of the nerve. Inanatomy, a dermatome is an area of the skin for which its sensory inputto the brain is mainly supplied by one of the thirty-one major spinalnerves. The locations of these areas are well known. Thus, the sensorystimuli to the brain from the area of the skin supplied by one of thesenerves is considered dermatomal. Sensory disturbances that do notcorrespond to a dermatomal pattern are known as non-dermatomal. If thesymptoms or sensory losses are in a dermatomal pattern it indicatesdamage to a nerve root(s) such as a herniated disc. Non-dermatomalpatterns indicate damage distal to a nerve root like a burn. Anexplanation and picture of nerve dermatomes can be found athttp://en.wikipedia.org/wiki/Dermatome_%28anatomy%29.

In one or more embodiments, the treatment information may includenon-dermatomal patterns and/or dermatomal patterns.

A “nerve root” is the base and initial segment of a nerve leaving thecentral nervous system as it branches off the spinal cord between thevertebrae allowing motor, sensory, and other signals to be sent to andfrom the extremities (e.g., to interact with the peripheral nervoussystem). Among others, there are cervical spine (neck) nerve roots,thoracic spine (middle back) nerve roots, lumbar spine (lower back)nerve roots, sacral (pelvic) nerve roots, and cranial (cerebrum orbrainstem) nerve roots.

The phrase “selected tissue in proximity” in the context of “selectedtissue in proximity to a nerve root” and “selected tissue in proximityto a nerve” refers to the skin and tissue in the area overlying and/orsurrounding the cells of the nerve root or nerve. Further, the term“proximity” may be empirically determined by the practitioner bearing inmind the inverse relationship between a laser’s effective power anddistance from the target treatment area. For example, “proximity” can bewithin 1 inch or less, or 0.5 inch or less, from the nerve or nerveroot.

The phrase “sensory impairment” refers to one or more unpleasant(subjectively and/or objectively determined) symptoms or sensationsassociated with a physical condition, such as peripheral neuropathy,including, e.g., pain (aching or shooting), soreness, tingling, burning,numbness, stiffness, lack of sensation, altered proprioception, loss ofbalance, coordination impairment, gait impairment, feelings ofcompression, diminished hot and cold sensation, phantom hot and coldsensation, muscle weakness, etc. Sensory impairment can be a loss of, orover-sensitization to, a feeling (e.g., touch) - hyposensitivity orhypersensitivity.

The phrase “vascular impairment” refers to one or more unpleasantsymptoms, sensations, and/or characteristics, associated with bloodcirculation conditions, such as damage to the capillaries due todiabetes, including, e.g., pale skin, reddish skin, purpled skin, and/orloss of color, symptoms of claudication (eg., fatigue, heaviness,tiredness, or cramping during activity), pain that disturbs sleep, soresor wounds that heal slowly or poorly, lower skin temperatures, poor ordecreased hair and/or nail growth, chronic widespread pain, fatigue,heightened pain in response to tactile pressure (allodynia), tingling,prolonged muscle spasms, weakness, nerve pain, muscle twitching,fasciculations, functional bowel disturbances, chronic sleepdisturbances, etc Although the exemplary systems and methods disclosedherein focus on treatment of sensory impairment, the disclosure hereinis not limited to the treatment of sensory impairment and furthercontemplates the same or similar exemplary systems and methods for usein treatment of vascular impairment (e.g., reduction of vascularimpairment, angiogenesis, stimulation of tissue growth, etc.).

The phrase “reduction of sensory impairment,” or “reduction of vascularimpairment,” refers to a lessened degree (subjectively and/orobjectively determined) of one or more of the unpleasant symptoms orsensations described above (e.g., which may be due to nerve and/ortissue repair and/or growth). This can include the patient’s perceptionof reduction of, including absence of, these unpleasant symptoms orsensations.

The term “extremity” refers to a site, which includes peripheral nerves,at any distance from the nerve root in a patient, including buttocks,legs, arms, feet, and hands. The terms “comprises” and variationsthereof do not have a limiting meaning where these terms appear in thedescription and claims.

The terms “preferred” and “preferably” refer to embodiments of thedisclosure that may afford certain benefits, under certaincircumstances. However, other embodiments may also be preferred, underthe same or other circumstances. Furthermore, the recitation of one ormore preferred embodiments does not imply that other embodiments are notuseful, and is not intended to exclude other embodiments from the scopeof the disclosure.

The terms “a,” “an,” “the,” “at least one,” and “one or more” are usedinterchangeably herein. Thus, for example, a computer system thatcomprises “a” display apparatus can be interpreted to mean that thecomputer system includes “one or more” display apparatuses.

The term “or” is generally employed herein in its usual sense including“and/or” unless the content clearly dictates otherwise. The term“and/or” means one or all of the listed elements or a combination of anytwo or more of the listed elements. The phrase “at least one of A and B”means A and/or B.

All numbers herein are assumed to be modified by the term “about” andpreferably by the term “exactly.” As used herein in connection with ameasured quantity, the term “about” refers to that variation in themeasured quantity as would be expected by the skilled artisan making themeasurement and exercising a level of care commensurate with theobjective of the measurement and the precision of the measuringequipment used. Also herein, the recitations of numerical ranges byendpoints include all numbers subsumed within that range and include itsendpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

The above summary of the present disclosure is not intended to describeeach disclosed embodiment or every implementation of the presentdisclosure. The description that follows more particularly exemplifiesillustrative embodiments and not limiting applications. In severalplaces throughout the application, guidance is provided through lists ofexamples, which examples can be used separately or in variouscombinations. In each instance, the recited list serves only as arepresentative group and should not be interpreted as an exclusive list.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of an exemplary method of reducing sensoryimpairment in a patient’s extremity.

FIG. 2 is block diagram of an exemplary computer system for use intreating one or more patient’s sensory impairment.

FIG. 3 is a block diagram of an exemplary method for use in treating apatient’s sensory impairment.

FIG. 4 is a more-detailed block diagram of the initial consultation ofthe exemplary method of FIG. 3 .

FIG. 5 is a more-detailed block diagram of the treatment(s) of theexemplary method of FIG. 3 .

FIG. 6 is a block diagram of an exemplary system for use in treating oneor more patient’s sensory impairment.

FIG. 7 is a block diagram of the therapy system of the exemplary systemof FIG. 6 .

FIG. 8 is an exemplary input interface for a leg.

FIG. 9 is an exemplary input interface for an arm.

FIG. 10 is an exemplary input interface for a foot.

FIG. 11A is a block diagram of an exemplary method of generating atreatment plan for a patient’s sensory impairment.

FIG. 11B is an exemplary table for use in generating a treatment planfor a patient’s sensory impairment.

FIG. 12 is an exemplary treatment display for a patient’s leg.

FIG. 13 is an exemplary treatment display for a patient’s arm.

FIG. 14 is an exemplary treatment display for a patient’s back.

FIGS. 15A-15D are exemplary graphical user interfaces for use ininputting objective measurement data, e.g., in an initial consultationsuch as the initial consultation of FIG. 4 , periodic reexaminationsduring the course of care, etc.

FIGS. 16A-16C are exemplary graphical user interfaces for use ininputting subjective patient data, e.g., in a treatment such as thetreatment of FIG. 5 .

FIGS. 17A-17D are exemplary graphical user interfaces for use in atreatment, e.g., in a treatment such as the treatment of FIG. 5 .

FIGS. 18A-18B are exemplary graphical user interfaces for use indisplaying data such as, e.g., objective measurement data, etc.

FIG. 19 is a table including results for the patients that haveunderwent therapy using the exemplary method and system describedherein.

FIGS. 20-22 are graphical representations of the results shown in FIG.19 .

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

In the following detailed description of illustrative embodiments,reference is made to the accompanying figures of the drawing which forma part hereof, and in which are shown, by way of illustration, specificembodiments which may be practiced. It is to be understood that otherembodiments may be utilized and structural changes may be made withoutdeparting from (e.g., still falling within) the scope of the disclosurepresented hereby.

Exemplary methods, apparatus, and systems shall be described withreference to FIGS. 1-22 . It will be apparent to one skilled in the artthat elements or processes from one embodiment may be used incombination with elements or processes of the other embodiments, andthat the possible embodiments of such methods, apparatus, and systemsusing combinations of features set forth herein is not limited to thespecific embodiments shown in the Figures and/or described herein.Further, it will be recognized that the embodiments described herein mayinclude many elements that are not necessarily shown to scale. Stillfurther, it will be recognized that timing of the processes and the sizeand shape of various elements herein may be modified but still fallwithin the scope of the present disclosure, although certain timings,one or more shapes and/or sizes, or types of elements, may beadvantageous over others.

The present disclosure provides systems and methods that use, forexample, therapeutic laser apparatus (e.g., Class IV therapeutic lasers)for reducing sensory impairment (e.g., pain, soreness, tingling,burning, numbness, stiffness, sense of balance/coordination/gait,whether acute, transient, or chronic) associated with, e.g., peripheralneuropathy, in a patient’s body portion, e.g., extremity (e.g., leg,arm, foot, hand, buttock). Such systems and methods may involvedelivering photonic energy to selected tissue (e.g., skin and underlyingtissue) for a sufficient time (e.g., time per treatment, number oftreatments), intensity (e.g., power in Watts applied to any particularlocation (e.g., point, region, area, etc.) or energy in Joules appliedper treatment), and frequency (e.g., treatments per day, week, or month,and intervals between treatments) to reduce sensory and/or vascularimpairment.

A Class IV laser is one that has greater power than a Class 3B laser.Specifically, a Class 3B laser is hazardous if the eye is directlyexposed, but diffuse reflections from matte surfaces are not harmful.Class 3B continuous lasers emit in wavelength ranges from 315 nanometers(nm) to far infrared and are limited to power levels of 0.5 (one-half)watt. Class 3B pulsed lasers emit wavelengths between 400 and 700 nm andare limited to 30 Milliwatts (mW). Thus, lasers with higher power,broader emission spectra, and greater penetration than a Class 3B laserare considered “Class IV” lasers.

The photonic energy may be applied by a therapeutic laser (e.g., a ClassIV laser). The photonic energy can be modulated, for example, by varyingthe wavelength, waveform, frequency, amplitude, etc. of the laser light.The energy can also be modulated by using a static or pulsing pattern(e.g., further the pulsing pattern energy can be varied). Exemplarytherapeutic laser apparatus is described further herein, e.g., withrespect to FIG. 7 .

Methods of the present disclosure use energy, such as photonic energy(e.g., laser energy), at elevated dosages that achieve therapeuticbenefit while limiting the damage to the tissue exposed to this energy,although minor irritation may occur, which can be reduced by reducingthe exposure times and/or by the use of a skin cooling apparatus (e.g.,the skin cooling systems produced by ZIMMER MEDIZINSYSTEMS).

In certain embodiments, systems and methods of the disclosure usenon-contact treatment methods (e.g., methods that do not requirepressure to be applied to the surface of the skin), using, for example,a treatment hand-piece that delivers the photonic energy (e.g., from ¼to 3 inches away from the skin). In certain embodiments, systems andmethods of the disclosure involve contact, such as massaging action,with a treatment hand-piece that delivers the photonic energy. In atleast one embodiment, the contact to the skin may move some bloodoutside of the region of skin that is being exposed to photonic energy,e.g., so as to increase the penetration depth of the photonic energy.

One or more exemplary effective therapeutic lasers have the powercapacity to deliver photonic energy with the necessary power topenetrate through the skin and underlying tissue surrounding theaffected nerve cells, whether at the nerve root, in surrounding and/oradjacent tissue or skin, or at a distal location to the affected nerveroot or cells, e.g., in an extremity (e.g., the leg, foot, buttock, arm,hand). In this context, “penetrate through” means, for example, toabsorb, and does not include an invasive surgical procedure like cuttingor injecting through the skin or tissue.

In certain embodiments, a method of the present disclosure includesreducing sensory impairment in a patient’s extremity by: exposingselected tissue in proximity to a selected nerve root (of a nerveimplicated in, or suspected of being, the cause of the sensoryimpairment) to photonic energy from a therapeutic laser (e.g.,delivering photonic energy to the selected tissue) at a power of atleast 6.5 Watts; and exposing selected tissue of an affected extremityin proximity to a nerve (implicated in, or suspected of being, the causeof the sensory impairment) extending from the selected nerve root tophotonic energy from a therapeutic laser at a power of at least 5.5Watts.

Typically, exposing selected tissue of an affected extremity involvestranslocating the photonic energy along the length of the extremityfollowing the path of the underlying peripheral nerve axis (e.g., a pathextending along the center of a peripheral nerve from a proximal end toa distal end) as close to the nerve as possible or permitted byphysiological or pathological circumstances. This can be varieddepending on the location of the sensory impairment. That is, treatmentsmay include application of photonic energy to portions of the length ofa nerve axis. In certain embodiments, the first or first few treatmentsmay include applying photonic energy along the entire length of theextremity (e.g., the entire leg), and later treatments may includeapplying photonic energy to only a portion thereof (e.g., the lower legfrom the knee to the ankle).

In certain embodiments, exposure may occur bilaterally for treatment ofpain in two extremities, e.g., both legs, both arms, or both buttocks.The extremity with the worst damage is usually used to dictate the levelof power and energy to apply to both extremities (e.g., both arms orboth legs), although treatment definitions or protocols can be varied toallow for differential power and energy application to each extremity.

In certain embodiments, exposure may occur in an initial treatment andin a series of treatments in a therapeutic protocol. Thus, variousembodiments of the present method may involve a sequential treatment,wherein a patient is typically treated at a frequency of from 1 or moretimes daily and/or 1 or more times each week, each for a period of from5 minutes to 60 minutes per treatment. Transitory response may beobserved after 1 treatment or 2 treatments and longer lasting responsemay require additional treatments, which, in chronic neuropathy, forexample, may be required for a period coextensive with the remainder ofthe patient’s life. A frequency may be, for example, from 1 treatment to5 treatments weekly, or 1 to 3 treatments weekly, with a duration, forexample, from 10 minutes to 50 minutes per treatment. The total numberof treatments can range, for example, from 1 treatment to 150 treatmentsper year. The patient may be treated for a duration, for example, from 1week to 12 weeks, from 2 weeks to 10 weeks, etc. The time betweentreatments is preferably 1 day to 2 days, although treatments can occurevery other week, for example, toward the end of the treatment plan. Thefrequency and duration of treatment, as well as the total number oftreatments, depends, in part, on the severity and duration of thesensory impairment. Periodic treatments may occur over the lifespan of apatient to address potential recurring sensory impairment and/orvascular impairment.

Systems and methods of the present disclosure can be used to reducesensory impairment associated with peripheral neuropathy. Peripheralneuropathy is neuropathy or damage to the nerves of the peripheralnervous system. It includes neuritis, which is inflammation of a nerve,and neuralgia, which is pain due to a nerve.

It has been discovered that the effectiveness of the present disclosureas described herein can be enhanced by applying photonic energy to thenerve root of a nerve implicated in, or suspected of being, the cause ofa patient’s sensory impairment, in addition to applying photonic energyto the nerve implicated in, or suspected of being, the cause of apatient’s sensory impairment as shown in the exemplary method 10depicted in FIG. 1 . Typically, applying photonic energy to the nerveroot or nerve is carried out by exposing selected tissue in proximity tothe selected nerve root or nerve to the photonic energy (block 12). Incertain embodiments, for example, as shown in FIG. 1 , exposing selectedtissue in proximity to a selected nerve root to photonic energy occursbefore exposing selected tissue of an affected extremity in proximity toa nerve extending from the selected nerve root (block 14). In certainembodiments, exposing selected tissue in proximity to a selected nerveroot to photonic energy (block 12) occurs after exposing selected tissueof an affected extremity in proximity to a nerve extending from theselected nerve root (block 14).

In certain embodiments, application of photonic energy to a selectednerve root can be carried out by exposing selected tissue in proximityto the selected nerve root to photonic energy (block 12) for at least 1minute, at least 2 minutes, at least 3 minutes, at least 4 minutes, atleast 5 minutes, or even more depending on the discretion of thehealthcare practitioner and the ability of the patient to toleratepotential discomfort during the treatment. In certain embodiments,application of photonic energy to a selected nerve root can be carriedout by exposing selected tissue in proximity to the selected nerve rootto photonic energy (block 12) for no longer than 20 minutes, no longerthan 15 minutes, no longer than 10 minutes, no longer than 9 minutes, nolonger than 8 minutes, no longer than 7 minutes, no longer than 6minutes, no longer than 5 minutes, no longer than 4 minutes, no longerthan 3 minutes, or even less time depending on the discretion of thehealthcare practitioner and the ability of the patient to toleratepotential discomfort during the treatment.

In this context, “exposure” means application of photonic energy to theskin through a non-contact or contact manner. For example, in anon-contact methodology a treatment hand-piece can be used that deliversthe photonic energy whereby the treatment hand-piece does not physicallytouch the skin. In a non-contact methodology, the treatment hand-piececan, for example, be held above the skin at a distance of no greaterthan 2 inches. In a contact methodology, for example, a treatmenthand-piece that delivers the photonic energy can be used whereby thetreatment hand-piece physically touches the skin, which can occur with arange of pressures, including using a massaging action.

In certain embodiments, application of photonic energy to a selectednerve can be carried out by exposing selected tissue in proximity to theselected nerve extending from the selected nerve root to photonic energy(block 14) for at least 5 minutes, at least 6 minutes, at least 7minutes, at least 8 minutes, at least 9 minutes, at least 10 minutes, oreven more depending on the discretion of the healthcare practitioner andthe ability of the patient to tolerate potential discomfort during thetreatment. In certain embodiments, application of photonic energy to aselected nerve can be carried out by exposing selected tissue inproximity to the selected nerve (e.g., extending from the selected nerveroot) to photonic energy (block 14) for no longer than 20 minutes, nolonger than 15 minutes, no longer than 10 minutes, no longer than 9minutes, no longer than 8 minutes, no longer than 7 minutes, no longerthan 6 minutes, no longer than 5 minutes, no longer than 4 minutes, nolonger than 3 minutes, or even less time depending on the discretion ofthe healthcare practitioner and the ability of the patient to toleratepotential discomfort during the treatment.

The rate at which photonic energy (e.g., a treatment hand-piece thatdelivers the photonic energy) is moved over the treatment site of theselected tissue may vary, but may be at a rate that allows the photonicenergy to provide an observable change in one or more of the treatmentsite’s visual characteristics (e.g., coloration, pattern, speckling,sparkle, etc.), which may, e.g., indicate actual penetration of photonicenergy through and into the tissue. For example, “speckling” of thephotonic energy beam may be observed (e.g., by the healthcarepractitioner) after the beam has been located over the selected tissuefor a period of time. In one or more embodiments, the rate at which thephotonic energy is moved along the treatment site as indicated by anobservable change in one or more of its visual characteristics may be 1inch per second or slower to the thermal tolerance of the patient.

In certain embodiments, exposure of the selected tissue occurs for aperiod of time sufficient to deliver a total dosage of at least 5000Joules, at least 5500 Joules, at least 6000 Joules, at least 6500Joules, at least 7000 Joules, at least 7500 Joules, at least 8000Joules, at least 8500 Joules, or at least 9000 Joules, or even moreenergy, per treatment (including the total energy applied to both thenerve, nerve root, skin, and the surrounding tissue). Typically, no morethan 25,000 Joules of energy is applied per treatment, although morecould be applied (e.g., 50,000 Joules). Thus, an upper limit of appliedenergy is not necessarily a limitation of a treatment plan according tothe present disclosure.

A treatment plan can include a series of treatments occurring over aperiod of days, weeks, or months. For example, an initial treatmentincludes: exposing selected tissue in proximity to a selected nerve rootto photonic energy (block 12) from a therapeutic laser (preferably, aClass IV therapeutic laser) at a power of at least 6.5 Watts; andexposing selected tissue of an affected extremity in proximity to anerve extending from the selected nerve root to photonic energy (block14) from a therapeutic laser (preferably, a Class IV therapeutic laser)at a power of at least 5.5 Watts. In certain embodiments, in subsequenttreatments in a treatment plan, the same amount, a higher amount, or alower amount, of power (in Watts) or energy (in Joules) can be appliedto the patient. This depends, for example, on whether the initialtreatment, or subsequent treatment, results in a desired level ofimprovement in sensory impairment, the desired rate of improvement, andthe ability of the patient to tolerate discomfort during treatment.

For example, subsequent treatments can include exposing the selectedtissue in proximity to the selected nerve root to photonic energy (block12) from a therapeutic laser (preferably, a Class IV therapeutic laser)at a power of at least 6.5 Watts, at least 6.75 Watts, at least 7 Watts,at least 7.25 Watts, or at least 7.5 Watts. Alternatively, subsequenttreatments can include exposing the selected tissue in proximity to theselected nerve root to photonic energy (block 12) from a therapeuticlaser (preferably, a Class IV therapeutic laser) at a power of at lessthan 6.5 Watts, less than 6.25 Watts, less than 6 Watts, less than 5.75Watts, or less than 5.5 Watts.

For example, subsequent treatments can include exposing the selectedtissue of an affected extremity in proximity to a nerve extending fromthe selected nerve root to photonic energy (block 14) from a therapeuticlaser (preferably, a Class IV therapeutic laser) at a power of at least5.5 Watts, at least 5.75 Watts, at least 6 Watts, at least 6.25 Watts,at least 6.5 Watts, at least 6.75 Watts, at least 7 Watts, at least 7.25Watts, or at least 7.5 Watts. Alternatively, subsequent treatments caninclude exposing the selected tissue of an affected extremity inproximity to a nerve extending from the selected nerve root to photonicenergy (block 14) from a therapeutic laser (preferably, a Class IVtherapeutic laser) at a power of less than 5.5 Watts, less than 5.25Watts, less than 5 Watts, less than 4.75 Watts, less than 4.5 Watts,less than 4.25 Watts, or less than 4 Watts.

Whether it is being applied to a nerve root in an initial treatment orin subsequent treatments, certain embodiments of the method of thepresent disclosure typically include exposing the selected tissue inproximity to the selected nerve root to photonic energy from atherapeutic laser (preferably, a Class IV therapeutic laser) at a powerof typically no less than 1 Watt. Whether it is being applied to a nerveroot in an initial treatment or in subsequent treatments, certainembodiments of the method of the present disclosure typically includeexposing the selected tissue in proximity to the selected nerve root tophotonic energy from a therapeutic laser (preferably, a Class IVtherapeutic laser) at a power of typically no more than 20 Watts.

Whether it is being applied to a nerve extending from the selected nerveroot in an initial treatment or in subsequent treatments, certainembodiments of the method of the present disclosure typically includeexposing the selected tissue of an affected extremity (in proximity to anerve extending from the selected nerve root) of typically no less than1 Watt. Whether it is being applied to a nerve extending from theselected nerve root in an initial treatment or in subsequent treatments,certain embodiments of the method of the present disclosure typicallyinclude exposing the selected tissue of an affected extremity (inproximity to a nerve extending from the selected nerve root) oftypically no more than 20 Watts.

In certain embodiments described herein, the initial treatment in atreatment plan includes applying photonic energy to the nerve root of anerve implicated in, or suspected of being, the cause of a patient’ssensory impairment (by exposing the selected tissue in proximity to theselected nerve root to photonic energy), in addition to applyingphotonic energy to the nerve implicated in, or suspected of being, thecause of a patient’s sensory impairment (by exposing the selected tissuein proximity to the nerve extending from the selected nerve root tophotonic energy). Subsequent treatments, however, can include applyingphotonic energy to just the nerve root of a nerve implicated in, orsuspected of being, the cause of a patient’s sensory impairment (byexposing the selected tissue in proximity to the selected nerve root tophotonic energy), or to just the nerve implicated in, or suspected ofbeing, the cause of a patient’s sensory impairment (by exposing theselected tissue in proximity to the nerve extending from the selectednerve root to photonic energy), or to both.

The surface area of exposure to photonic energy at the nerve root (the“selected tissue in proximity to a nerve root”) may, for example, be atleast 1 square centimeter and no more than 1000 square centimeters. Thesurface area of exposure to photonic energy at the nerve in an extremitymay, for example, be at least 5 square centimeters and no more than15000 square centimeters.

Treatment plans can occur in phases depending on the progression ofsymptoms. For example, a first treatment phase for both legs and feetmay include 6 minutes at the nerve roots, 8 minutes for each leg equallydivided between the upper and lower legs, and 4 minutes for each foot.As the sensory impairment in each leg is reduced with the impression ofit (e.g., pain) being “driven out” of the leg through the foot, thesecond treatment phase may include 6 minutes at the nerve roots, 7minutes for each leg with more time spent on the lower legs than theupper legs, and 5 minutes for each foot. As the sensory impairment ineach leg is further reduced with the patient’s impression of it (e.g.,pain) being “driven out” (e.g., to move distally as if one were takingoff a sock) of the leg through the foot, a subsequent treatment phasemay include 6 minutes at the nerve roots, 4 minutes for each leg fromthe mid shin to the ankle, and 8 minutes for each foot. Further, if thesensory impairment becomes different, or similar, between twoextremities such as, e.g., a right leg and a left leg, subsequenttreatment phases may be shift more treatment time to the extremityhaving greater sensory impairment (e.g., more significant damage). Forexample, in a patient whose remaining symptoms are very mild on thedorsum of the left foot but twice as noticeable on the right foot, ⅔ ofthe treatment time may be shifted to the right foot while ⅓ of thetreatment time may remain on the left foot.

Although not intending to be limiting, it is believed that the methodsdescribed herein may be effective because they accomplish one or more ofthe following: (1) creation of Adenosine triphosphate (ATP) associatedwith nerve conduction or the enzymatic or metabolic pathways involved insaid ATP creation; (2) increase the kinetic activity of the ATP toincrease its interaction with the cell membrane; (3) deliver theappropriate nutrients to the site needed for proper functioning of thenerve cell and for repair of any cellular damage; and (4) affectunderlying biomechanical or metabolic dysfunction that may becontributing to the symptomatic profile.

Creation of ATP may be responsible, when it connects the receptors onthe membrane of the damaged nerve cell, for “opening” that membrane andfacilitating the absorption of nutrients needed for proper function andhealing of that damaged cell. The ATP under consideration may be thatwhich is created as a result of a process that begins with theexcitement of photoreceptive molecules, including but not limited to,NADH or Cytochrome-C molecules, and this may be accomplished with thedelivery of very specific frequencies of photonic energy to thosemolecules. Increasing the kinetic activity of ATP may sufficiently causethe kinetic energy of the ATP to overcome the activation energy barrierand may connect to the nerve cell membrane in an enzyme-substratecomplex that enables the transfer of nutrients into the nerve cell. Thisstimulation may be accomplished by heating the water in surroundingtissue and, with the resulting heat transfer to ATP, increasing thekinetic energy of the ATP. Alternatively, GTP-coupled receptor systemsand/or G-Protein coupled receptor systems may be implicated in themechanism of action by which photonic energy participated in tissuerepair, more specifically, repair of neurological repair.

For a laser, typically a Class IV therapeutic laser, to be effectivelyused in one or more embodiments of the methods and systems describedherein, it is desirable and preferable for the laser to emit frequenciesthat are optimized to effect the excited-state reactions ofphotoreceptive molecules, including but not limited to, NADH orCytochrome-C molecules needed for the production of ATP, and frequenciesoptimized to the absorption range of the water molecules in thesurrounding tissue. Further, it is desirable and preferable for thelaser to deliver these frequencies with sufficient power to penetratetissue without significant dissipation, so that adequate energy isdelivered at the needed site of damage. Specifically, at least in oneembodiment, it is desirable and preferable that the photonic energy bedelivered at a frequency, and with enough power, that will stimulate theproduction of ATP and cause the heat absorption of water and theconcurrent stimulation of ATP, such that it will increase the number ofinteractions between ATP and the nerve cell membrane.

Generally, a therapeutic laser apparatus to be used in the exemplarymethods and systems described herein may be any apparatus capable ofdelivering or emitting photonic energy at a wavelength from 500nanometers to 1000 nanometers at a power from 0.5 Watts to 30 Watts.Further, the therapeutic laser apparatus may be capable of deliveringphotonic energy at one or more fixed and/or selectable wavelengthseither simultaneously or separately (e.g., 800 nanometers, 970nanometers, etc.). Still further, the therapeutic laser apparatus mayalso be capable of delivering pulsed photonic energy in a frequencyrange, e.g., from 0.5 Hertz to 40,000 Hertz. In at least one embodiment,each of the following parameters of the therapeutic laser may beadjustable, e.g., by a therapist or a control system (e.g., a localsystem 130 as described herein with reference to FIGS. 6-7 ): power,wavelength, time, duty cycle, frequency, energy, average power, focallength, etc. Further, the therapeutic laser apparatus may also becapable of delivering collimated and/or divergent photonic energy. Also,the therapeutic laser apparatus may also be capable delivering photonicenergy having an output spot size of 0.25 square centimeters to 10square centimeters.

Methods of the present disclosure involve a “reduction of sensoryimpairment,” which refers to a lessened degree of one or more unpleasantsymptoms in one or more of a patient’s extremities, including, forexample, pain (aching or shooting), soreness, tingling, burning,numbness, stiffness, lack of sensation, altered proprioception, loss ofbalance, coordination impairment, feelings of compression, diminishedhot and cold sensation, phantom hot and cold sensation, muscle weakness,etc. Such unpleasant symptoms are often associated with a physicalcondition such as peripheral neuropathy (including neuropathy associatedwith, or resulting from, diabetes, chemotherapy, injuries, surgery), orother conditions. Methods of the present disclosure involve evaluationof a patient’s sensory impairment before treatment to assist in ahealthcare practitioner’s determination of treatment information (e.g.,treatment plans, treatment definitions, therapeutic protocols, etc.). Atvarious times throughout a treatment plan, the level of sensoryimpairment may be evaluated to evaluate the effectiveness of thetreatments and to modify the treatments if necessary.

Further, the exemplary methods and systems described herein mayadditionally, or alternatively, be used to treat vascular impairment.For example, the exemplary methods and systems used to reduce sensoryimpairment may be used to reduce vascular impairment (including, e.g.,the one or more unpleasant systems associated with the vascularimpairment). The vascular impairment may be associated with bloodcirculation conditions, such as damage to the capillaries due todiabetes, etc., and may include one or more of following symptoms: paleskin, reddish skin, purple skin, or loss of color, symptoms ofclaudication (e.g., fatigue, heaviness, tiredness, or cramping duringactivity), pain that disturbs sleep, sores or wounds that heal slowly orpoorly, lower skin temperatures, poor or decreased hair and/or nailgrowth, chronic widespread pain, fatigue, heightened pain in response totactile pressure (allodynia), tingling, prolonged muscle spasms,weakness, nerve pain, muscle twitching, fasciculations, functional boweldisturbances, chronic sleep disturbances, etc.

Nerve damage and/or peripheral neuropathy (PN) may be acute, transient,or chronic. While the timing and duration of peripheral neuropathy maybe characterized using different terms, an “acute” condition is usuallyassociated with rapid onset and relatively short duration (minutes,hours, and/or days). In contrast, “transient” may be used tocharacterize conditions that are variable in both intensity and durationand/or have not reached a steady-state. “Chronic” peripheral neuropathyand/or other conditions are those that are persistent and/orlong-lasting in nature, usually lasting longer than three months. Themethods described herein are particularly effective for reducing sensoryimpairment associated with chronic conditions, such as chronicperipheral neuropathy.

Toxic agents used in therapeutic settings, such as chemotherapeuticagents, that selectively, or more strongly, affect cancerous cells thannormal cells and tissues may also result in peripheral neuropathy. Themethods described herein are particularly effective for reducing sensoryimpairment associated with peripheral neuropathy resulting fromchemotherapy.

The localization of sensory impairment assists the healthcarepractitioner in identifying the nerves and nerve roots to be treated.The level of general sensory impairment assists the healthcarepractitioner in determining the level of power (in Watts) and energy (inJoules) to be used at any particular location, the number of treatments,and the frequency of treatments to reduce sensory impairment.

A treatment plan and/or a treatment definition can also includeconventional chiropracticlike manipulations, e.g., tractionmanipulation, use of an activator adjustment instrument, etc. Atreatment plan and/or a treatment definition can also include a focus onaddressing motor function problems by increasing the range of motion ofan affected area. For example, a stretching regime, typically carriedout between laser treatments, can be used for added advantage ifdesired. Stretching can help with the soft tissue shrinkage of theconnective tissues commonly associated with neuropathy and reducingfascial pain. Such stretches can be for the feet, legs, arms, hands,etc., depending on the affected extremity. A treatment plan and/or atreatment definition that includes such a focus on addressing motorfunction problems can also improve problems with balance andcoordination.

Exemplary methods of treating (e.g., reducing) sensory impairmentdescribed herein may utilize one or more computer systems, e.g., in thegeneration of treatment information, in the collection of data regardinga patient’s sensory impairment, in control of therapeutic equipment suchas therapeutic lasers, etc. An exemplary computer system 15 depicted inFIG. 2 may be used for any of the exemplary methods and/or processeswithin such methods described herein.

The exemplary computer system 15 includes processing apparatus 16. Theprocessing apparatus 16 may be configured to receive input 20 (e.g.,subjective patient data, objective measurement data, cumulative patientdata, etc.) and to transmit output 21 (e.g., treatment information suchas treatment definitions, treatment plans, etc.) for use in treating apatient’s sensory impairment and/or vascular impairment. Further, theprocessing apparatus 16 includes data storage 17. Data storage 17 allowsfor access to processing programs or routines 18 and one or more othertypes of data 19 that may be employed to carry out exemplary methodsand/or processes for use in treating a patient’s sensory impairment(e.g., some of which are shown generally in the block diagrams of FIGS.4-5 ). For example, the computer system 15 may be configured to generatetreatment information based on patient data and measurement data.

The computer system 15 may be operatively coupled to a therapy system13. The therapy system 13 may be, e.g., any system operable to deliverphotonic energy therapy to a patient. The computer system 15 may provideoutput (e.g., treatment information) to the therapy system 13. Forexample, the computer system 15 may output a power level, and maytransmit the power level to the therapy system 13 such that the therapysystem 13 delivers photonic energy at that specific power level.Further, for example, the computer system 15 may output and transmitcontrol commands to the therapy system 13 such that the therapy system13 is controlled by the computer system 15.

The processing programs or routines 18 may include programs or routinesfor performing computational mathematics, matrix mathematics,standardization algorithms, comparison algorithms, vector mathematics,or any other processing required to implement one or more exemplarymethods and/or processes described herein. Data 19 may include, forexample, subjective patient data, objective measurement data, cumulativepatient data, treatment information such as treatment definitions andtreatment plans, graphical user interfaces, results from one or moreprocessing programs or routines employed according to the disclosureherein, or any other data that may be necessary for carrying out the oneand/or more processes or methods described herein.

In one or more embodiments, the system 15 may be implemented using oneor more computer programs executed on programmable computers, such ascomputers that include, for example, processing capabilities, datastorage (e.g., volatile or non-volatile memory and/or storage elements),input devices, and output devices. Program code and/or logic describedherein may be applied to input data to perform functionality describedherein and generate desired output information (e.g., treatmentinformation). The output information may be applied as input to one ormore other devices and/or methods (e.g., therapy system 13) as describedherein or as would be applied in a known fashion.

The program used to implement the methods and/or processes describedherein may be provided using any programmable language, e.g., a highlevel procedural and/or object orientated programming language that issuitable for communicating with a computer system. Any such programsmay, for example, be stored on any suitable device, e.g., a storagemedia, readable by a general or special purpose program, computer or aprocessor apparatus for configuring and operating the computer when thesuitable device is read for performing the procedures described herein.In other words, at least in one embodiment, the system 15 may beimplemented using a computer readable storage medium, configured with acomputer program, where the storage medium so configured causes thecomputer to operate in a specific and predefined manner to performfunctions described herein.

Likewise, the system 15 may be configured at a remote site (e.g., anapplication server) that allows access by one or more users via a remotecomputer apparatus (e.g., via a web browser), and allows a user toemploy the functionality according to the present disclosure (e.g., useraccesses a graphical user interface associated with one or more programsto process data).

The processing apparatus 16 may be, for example, any fixed or mobilecomputer system (e.g., a personal computer, mini computer, tabletcomputer, etc.). The exact configuration of the processing apparatus 16is not limiting, and essentially any device capable of providingsuitable computing capabilities and control capabilities (e.g., controlof therapy apparatus, etc.) may be used. Further, various peripheraldevices, such as, e.g., a computer display, mouse, touchscreen,keyboard, memory, printer, scanner, etc., are contemplated to be used incombination with the processing apparatus 16.

Further, in one or more embodiments, the output (e.g., treatmentinformation such as treatment definitions and treatment plans, digitalfiles, files in user-readable format, etc.) may be analyzed by a user,used by another machine that provides output based thereon, etc. Asdescribed herein, a digital file may be any medium (e.g., volatile ornon-volatile memory, a CD-ROM, a punch card, magnetic recordable tape,etc.) containing digital bits (e.g., encoded in binary, trinary, etc.)that may be readable and/or writeable by processing apparatus 16described herein. Also, as described herein, a file in user-readableformat may be any representation of data (e.g., ASCII text, binarynumbers, hexadecimal numbers, decimal numbers, audio, graphical)presentable on any medium (e.g., paper, a display, sound waves, etc.)readable and/or understandable by a user. Generally, the methods andsystems as described herein may utilize algorithms implementingmathematics to generate treatment information described herein (e.g.,from subjective patient data, objective measurement data, cumulativepatient data, etc.).

In view of the above, it will be readily apparent that the functionalityas described in one or more embodiments according to the presentdisclosure may be implemented in any manner as would be known to oneskilled in the art. As such, the computer language, the computer system,or any other software/hardware which is to be used to implement theprocesses described herein shall not be limiting on the scope of thesystems, processes or programs (e.g., the functionality provided by suchsystems, processes or programs) described herein.

One will recognize that a graphical user interface may be used inconjunction with the embodiments described herein. The user interfacemay provide various features allowing for user input thereto, change ofinput, importation or exportation of files, or any other features thatmay be generally suitable for use with the processes described herein.For example, the user interface may allow default values to be used ormay require entry of certain values, limits, threshold values, or otherpertinent information.

The methods described in this disclosure, including those attributed tothe systems, or various constituent components, may be implemented, atleast in part, in hardware, software, firmware, or any combinationthereof. For example, various aspects of the techniques may beimplemented within one or more processors, including one or moremicroprocessors, DSPs, ASICs, FPGAs, or any other equivalent integratedor discrete logic circuitry, as well as any combinations of suchcomponents, or other devices. The term “processor” or “processingcircuitry” may generally refer to any of the foregoing logic circuitry,alone or in combination with other logic circuitry, or any otherequivalent circuitry.

Such hardware, software, and/or firmware may be implemented within thesame device or within separate devices to support the various operationsand functions described in this disclosure. In addition, any of thedescribed components may be implemented together or separately asdiscrete but interoperable logic devices. Depiction of differentfeatures, e.g., using block diagrams, etc., is intended to highlightdifferent functional aspects and does not necessarily imply that suchfeatures must be realized by separate hardware or software components.Rather, functionality may be performed by separate hardware or softwarecomponents, or integrated within common or separate hardware or softwarecomponents. When implemented in software, the functionality ascribed tothe systems, devices and methods described in this disclosure may beembodied as instructions on a computer-readable medium such as RAM, ROM,NVRAM, EEPROM, FLASH memory, magnetic data storage media, optical datastorage media, or the like. The instructions may be executed by one ormore processors to support one or more aspects of the functionalitydescribed in this disclosure.

As described herein, a patient’s sensory impairment may be treated byexposure of one or more body portions of the patient to photonic energyfrom a therapeutic laser over a therapy period. Such therapy period maybe broken into multiple processes including, e.g., an initialconsultation, one or more treatments, and one or morefollow-up/maintenance treatments. For example, a general method 22 foruse in treating a patient’s sensory impairment is shown in FIG. 3 .Method 22 includes an initial consultation 24, one or more treatments26, one or more follow-up/maintenance treatments 28, and one or moreevaluations 27.

For example, an assessment of the patient’s sensory impairment may beestablished and a treatment plan may be developed in an initialconsultation 24. The treatment plan generated in the initialconsultation may be based on the assessment of the patient’s sensoryimpairment.

For example, generation of a treatment plan 31, as shown in more detailin FIG. 4 , may include collecting subjective patient data 30 andcollecting objective measurement data 32 using one or more processes.Each of the subjective patient data and the objective measurement datais data that may be indicative of damage (e.g., sensory impairment) atdifferent damage regions of a body portion.

As used herein, “subjective patient data” may be defined as dataobtained through questioning a patient using, e.g., a form, a therapist,a graphical user interface, etc. Further, as used herein, “objectivemeasurement data” may be defined as data obtained through one or morephysical examination processes or methods designed to gather data thatcorresponds to a patient’s sensory impairment. For example, subjectivepatient data may be retrieved from a patient’s description of thesensory impairment or symptoms related to the sensory impairment whileobjective measurement data may be retrieved using physical examinationof the patient by a practitioner (e.g., doctor). Further, in some cases,certain data may be considered to contribute to one or both subjectivepatent data and objective measurement data.

The subjective patient data may be collected 30 from patient in variousways. For example, a patient may be presented with a form that thepatient may use to record or note various information with respect totheir sensory impairment. Exemplary patient input forms may includegraphical depictions of extremities, e.g., of a leg and an arm,respectively, and a plurality of questions to be answered for aplurality of areas (e.g., each area being labeled on the forms) of thebody portion. The patient may answer each of the questions for each areaby writing on the form itself, e.g., on the area itself, the side of thearea, etc. In one or more embodiments, the patient may not write on theform but may use the form while fielding questions from a therapist whomay enter the subjective patient data into a computer system (e.g.,which may be similar to the computer system 15 described herein withreference to FIG. 2 ) using a graphical user interface. In at least oneembodiment the patient may be presented with a graphical user interface(e.g., similar to the graphical user interfaces depicted in FIGS. 15-16) that the patient may use to record or note various information withrespect to their sensory impairment.

Each of the plurality of questions that may be answered by a patient maypertain to a particular sensation that the patient may feel with respectto each labeled area of the body portion and a value (e.g., on a scale)for each particular sensation with respect to each labeled area of thebody portion. For example, a patient may mark, or indicate, each labeledarea with one or more of the following sensations: pain intensity,shooting pain, tingling, numbness, burning or cold sensations, soreness,tightness, heaviness in the legs, sharp pins and needles, any additionalother sensations (e.g., written or marked in an “other” category), etc.Further, for each of these sensations, the patient may record a value ora ranking on a scale, such as a scale of 0 to 10, although other scalesmay be used. An exemplary scale of 0 to 10 for each of the sensationsmay be analogous to a numerical pain scale, wherein a rating of 0 = none(e.g., no pain), 3 = uncomfortable (e.g., mild pain that is nagging,annoying, but interferes little with activities of daily living), 5 =painful (e.g., uncomfortable to dreadful pain that interferessignificantly with activities of daily living), 7 = agonizing pain, and10 = unbearable pain (e.g., severe pain, disabling, and unable toperform activities of daily living). In at least one embodiment, anexemplary scale of 0 to 10 is also color-coded fading from green to redwherein green is at 0 and red is at 10. In at least one embodiment, anexemplary scale may include facial expressions to help obtain anaccurate measurement of pain.

In addition, for each sensation, the patient may further indicateparticular sensations with an initial such as, e.g., tingling with a“T,” burning heat or cold with a “B,” numbness with a “N,” and/ortightness with a “t.” Further, the patient may also indicate whether theparticular sensation has increased or decreased since the lastappointment or treatment using a “+” or a “-” sign next to the sensationinitial.

In other words, a patient may use a 0 to 10 scale and mark one or moreregions (e.g., 6 regions) of a leg, or one or more regions (e.g., 5regions) of the arm, for the level of sensations of pain, tingling,numbness, burning, heat, etc. Also, the type of pain (e.g., shooting),type of numbness (e.g., dull or padded), the frequency of the pain, andthe relative change in the degree of sensation (e.g., T+ for moretingling than the last visit, T- for less tingling; B+ for more burningthan the last visit, B- for less burning than the last visit) may alsobe characterized and marked on the one or more regions.

In at least one embodiment, the subjective patient data may be collectedusing a graphical user interface of a computer system. In essence, formsmay be presented in the form of a graphical user interface of a computersystem (e.g., which may be similar to the computer system 15 describedherein with reference to FIG. 2 such as a tablet computer) such that thepatient or a therapist interacting with the patient may use the computersystem to enter the subjective patient data. Exemplary graphical userinterfaces that may be used to collect subjective patient data aredepicted, e.g., in FIGS. 16A-16C.

As shown in FIGS. 16A-16C, a body portion 502 of a patient may bedepicted on graphical user interface 500, and multiple different damageregions 504 may be identified on the body portion 502. A user may use aninput interface (e.g., touch screen, mouse, keyboard, etc.) to inputdata indicative of damage for each different damage region 504 of thebody portion 502. As shown, the body portion 502 is an extremity of thepatient-more specifically, a leg is depicted in FIGS. 16A-16C. In otherembodiments, a foot or an arm may be depicted in an exemplary inputinterface. Further, the damage regions 504 (e.g., LE-11 to LE-1 for theleg) for each body portion 502 are consecutively located along theextremity, e.g., from the patient’s torso to a distal end of theextremity.

As shown in FIG. 16A, a user may select (e.g., click or touch) a damageregion 504, which initiates the appearance of a menu 506. The user maythen select a sensation of a plurality of sensations, such as, e.g.,neuropathy pain, tingling, paresthesis, tightness, temperaturesensation, etc. and a value for each sensation for each different damageregion 504 using the menu 506. In other embodiments, the plurality ofselected sensations may further include numbness, heat/burningsensation, cold/freezing sensation, etc. As shown, the menu 506 includesa “pull-down” selection function for each sensation within which a usermay select the value. The value for each sensation may be, e.g., anumerical value from 0 to 10, affirmative, negative, more, less, same,yes, no, dull, padded, completely numb, none, etc. The user may select avalue for each sensation for each of the damage regions 504 for the bodyportion 502 using the “pull-down” selection function for each sensation.After a value has been selected for a sensation, an icon 508 indicatingthe sensation and value may appear proximate the body portion 502 asshown in FIG. 16B.

A patient’s sensations may be similar from the most proximal (e.g.,nearest the torso) affected damage region 504 to the most distal end ofthe extremity. As such, the interface 500 may allow a user to selectmore than one damage region 504 to input the sensation and the valueassociated with the sensation at the same time. In other words, theinterface 500 may allow a user to simultaneously enter one or moresensations and values associated with each sensation for more than onedamage region 504, e.g., from a damage region to a more distal damageregion. For example, as shown in FIG. 16C, a user has selected damageregions 504 LE-10, LE-9, and LE-8 such that the inputted sensations andvalues for each sensation may be inputted for each such damage region504 LE-10, LE-9, and LE-8. In at least one embodiment (although notdepicted in FIG. 16B), the interface 500 may allow a user to copyinputted sensations and associated values to each damage region 504 fromthe inputted damage region 504 to the most distal damage region (e.g.,LE-1) (e.g., all the damage regions 504 between the damage region 504where data was inputted and the most distal damage region 504). Thisfunction, where all values are copied down the extremity from a moreproximal damage region may be referred to as “cascading” (e.g., using a“cascading” function).

Further, a patient’s sensations may be similar from one body portion 502to another corresponding body portion 502. For example, the sensationsin a patient’s left leg may be similar to the sensations in thepatient’s right leg. As such, the interface may allow a user to copy, or“mirror,” the inputted sensations and the inputted values for thesensations for the damage regions from one body portion to another(e.g., from the left leg to the right leg). This function may bereferred to as a “mirror” function 510 as shown in FIG. 16B.

The objective measurement data may also be collected 32 in various ways.Generally, the patient may be evaluated locally by a variety of clinicaldiagnostic tests, e.g., nerve conduction studies. Common tests used forlocalized evaluation of a patient’s subjective sensory impairmentinclude a vibratory test and a pinwheel test, as well as the Tinel’sTest and the Babinski Test. The vibratory test is used to test sensoryimpairment to a vibrating tuning fork. The pinwheel test is used to testsensory impairment to a pinwheel (e.g., Wartenberg pinwheel). TheTinel’s Test (i.e., Tinel’s Sign Test) is performed by lightly tapping(percussing) over the nerve to elicit a sensation of tingling or “pinsand needles” in the distribution of the nerve. It is commonly used intesting for carpal tunnel syndrome. The Babinski Test (i.e., BabinskiReflex or Babinski Sign Test) is a neurologic test based upon what thebig toe does when the sole of the foot is stimulated. The Babinskireflex is obtained by stimulating the external portion (the outside) ofthe sole. The practitioner may begin the stimulation (e.g., using theirthumb and applying firm pressure) moving from back to front starting atthe heel and moving forward to the base of the toes along the outsideedge of the foot. Further, skin temperature and/or colorationmeasurements as well as any other measurements or indicators associatedwith vascular impairment may also be collected and, e.g., used togenerate treatment information for treating vascular impairment.

Other tests that can be used include qualitative or quantitative tests.Such tests include, for example, Semmes Weinstein test in which pressureis applied against the skin of affected areas using monofilaments ofvarying thicknesses, hot-versus-cold test in which sensory impairment totemperature change is evaluated, the nerve conduction velocity test(NCV) and the needle electromyogram test (EMG), both of which measuresensory impairment by evaluating the conductivity of nerves. Any one ofthese tests or other clinical diagnostic tests, alone or in combination,could indicate sensory impairment resulting from peripheral neuropathy.

Further, to collect objective measurement data and/or subjective patentdata, a practitioner may perform measurements of the following and/ormay use the following tests: tibial pulse, dorsalis pedis, compressionof nerves at the Tarsal Tunnel and Fibular Heads each leg (e.g., theTinel’s Test), reflexes at the knee and Achilles tendon, presence orabsence of clonus, Babinski Sign Test, arm pulses, radial pulse, Ulnapulse, Carpal and Tarsal Tunnel (e.g., the Tinel’s Test), modified totalneuropathy score (mTNS), balance screening test, quality of life (QOL)tests (e.g., Neuro-QOL), etc.

The objective measurement data may also be entered into a computersystem, e.g., which may be similar to the computer system 15 describedherein with reference to FIG. 2 . For example, a practitioner may bepresented with a graphical user interface of a computer systempresenting various graphical depictions of body portions and may furtheruse the computer system record or enter various objective measurementdata with respect to the patient’s sensory impairment. An exemplary leginput graphical user interface 208 is depicted in FIG. 8 , an exemplaryarm input graphical user interface 209 is depicted in FIG. 9 , and anexemplary foot input graphical user interface 210 is depicted in FIG. 10. Each interface 208, 209, 210 includes graphical depictions of a leg,an arm, and a foot, respectively. Each of the leg, arm, and foot includea plurality of damage regions. The damage regions are consecutivelylabeled using, for example, an alphanumerical scale: Le1 to Le11 for theleg, H1 to A3 for the arm, and F1 to F6 for the foot. More specifically,the damage regions are consecutively located (and labeled) along eachextremity from a patient’s torso to a distal end of the extremity.Additional exemplary graphical user interfaces that may be used tocollect objective measurement data are depicted, e.g., in FIGS. 15A-15D.

An exemplary user interface that may be used to collect/input objectivemeasurement data may be similar to the user interface 500 that may beused to collect/input subjective patient data. For example, as shown inFIGS. 15A-15D, a body portion 602 of a patient may be depicted ongraphical user interface 600, and multiple different damage regions 604may be identified on the body portion 602. After selecting, e.g.,clicking, touching, etc., a damage region 604 as shown in FIG. 15B, amenu 606 may be displayed, or appear, that allows a user to select asensation, e.g., vibration, pinwheel, etc., and select a value to beassociated with that sensation, e.g., normal, hypo, hyper, absent, etc.After a sensation and value have been selected for a damage region 604,one or more icons 610 may appear proximate the damage region 604indicating the sensation and value. As described herein with referenceto interface 500 of FIGS. 16A-16C, the sensation and the valuesassociated with that sensation may be inputted into multiple damageregions simultaneously or copied from one damage region to multipledamage regions (e.g., “cascaded”) or to another body portion (e.g.,“mirrored”).

Further shown in FIG. 15B is an area for indicating whether the damageregion is symptomatic of peripheral neuropathy. For example, apractitioner may select a “yes” or a “no” for each damage region (e.g.,indicating whether such damage region is symptomatic of peripheralneuropathy). For example, if a patient tells a practitioner that he/shehas symptoms in a damage region (e.g., one or more damage regions) thatare indicative of peripheral neuropathy, then the practitioner mayselect a “yes” value for that damage region. Such subjective symptomaticdata may be used to modify, or append, certain treatment informationsuch as, e.g., described in reference to FIG. 11A.

As shown in FIG. 15B, hypo was selected in the vibration sensation testand hyper was selected for the pinwheel sensation test for damage levelLE-8. If a user selected the “cascade” function 608 in FIG. 15B, theremaining damage regions from damage level LE-8 to the distal end of theextremity would receive the same sensations and values as inputted atdamage level LE-8. As shown in FIG. 15C, a user has selected hypovibration and cascaded the values downwardly from LE-8. Further, if auser selects the “mirror” function 612 in FIG. 15C, the other extremity,i.e., the left leg, will receive the same sensations and values asinputted for the right leg. Additional values have been indicated inFIG. 15D.

Further, one or more temperature targets may be labeled on the graphicaldepictions of the leg, arm, and foot in the interfaces 208, 209, 210,which may be used to indicate one or more areas where skin surface maybe measured using a temperature detector. Such temperatures may also beentered into a computer system using, e.g., the graphical userinterfaces of FIGS. 8-10 and 15A-15D.

Although subjective patient data and objective measurement data aredescribed herein separately, various tests, questions, and/ormeasurements may be both subjective and objective. For example,objective measurement tests may be modified by patient input, andtherefore, could be considered to include subjective data. Further,although subjective patent data is referred to as being “subjective,”subjective patient data may include objective data. Likewise, althoughobjective measurement data is referred to as “objective,” objectivemeasurement data may include subjective data. In essence, although theterms subjective patient data and objective measurement are describedseparately herein, the use of the words subjective and objective withinsuch terms is not meant to limit the data in any way. Further, varioustests may include subjective and objective components. For example, amodified Total Neuropathy Score may include subjective questions (e.g.,with respect to paresthesias (tingling)) and objective measurements(e.g., vibration).

After the subjective patient data has been collected 30 and/or theobjective measurement data has been collected 32, treatment informationmay be generated 34. The treatment information may be generated 34 usingan algorithm in a computer system, e.g., the computer system 15described herein with reference to FIG. 2 . The algorithm may use thesubjective patient data and/or the objective measurement data, i.e.,inputs, to generate the treatment information, i.e., the output. Thetreatment information generated in method 31 may include one or more oftreatment plans, treatment definitions (e.g., phase treatments), and/orany other information for defining a treatment or delivery of suchtreatment. An exemplary treatment plan may include an estimated numberof treatments (e.g., including photonic energy treatments, stretchingexercises, and/or other various treatments) and an amount of time, ortime period, per treatment to treat a patient’s sensory impairment.

One exemplary method of generating a treatment plan for a patient’ssensory impairment is depicted in FIG. 11A. Generally, the method 400includes collecting subjective data and objective measurement data 402,modifying the damage level 403, determining the number of treatments forthe treatment plan 404, and determining the amount of time per treatmentfor the treatment plan 406. As shown, collecting subjective and/orobjective measurement data 402 includes collecting subjectivesymptomatic data (e.g., indicative of peripheral neuropathy, notingwhere symptomatic areas are located for the arms and legs, etc.) andmeasuring vibration loss and pin prick loss in the arms and legs of thepatient. Although not shown, such subjective and/or objectivemeasurement data may be inputted into a computer system, e.g., computersystem 15 as described herein with reference to FIG. 2 .

In certain situations, a patient may have symptoms indicative ofperipheral neuropathy that do not completely correspond to the objectivemeasurement data. In these situations, it may be beneficial to modify403, or append, the damage determination, or worst damage (D) (e.g.,determined by the objective measurement data) by the symptoms. In otherwords, the worst damage (D) may be modified 403 by symptomaticmeasurements (S). Generally, for the legs, if the symptomatic area isdramatically lower than the areas of vibration and pinprick loss, then Dmay be reduced. Further, for the arms, in many cases the vibration andpin prick measurements may be normal (e.g., not indicative ofneuropathy), but yet the patients are still symptomatic (e.g.,indicative of neuropathy)-in this case, D be increased for the armsaccordingly.

For example, as shown in FIG. 11A, for the arms, D may be set to theworst (e.g., most proximal such as closest to the torso of the patient)damage (Di) (e.g., measured using objective measurement techniques,etc.) or symptoms (S) indicative of neuropathy. Further, for the legs,if the symptoms (S) indicate neuropathy at LE-1 and damage (Di) ismeasured at greater than or equal to LE-8, then D may be reduced toLE-5. If the symptoms (S) indicate neuropathy at LE-1 and damage (Di) ismeasured at greater than or equal to LE-5 and less than LE-8, then D maybe reduced to LE-4. If the symptoms (S) indicate neuropathy at LE-2 anddamage (Di) is measured at greater than or equal to LE-8, then D may bereduced to LE-5. If the symptoms (S) indicate neuropathy at LE-2 anddamage (Di) is measured at greater than or equal to LE-6 and less thanLE-8, then D may be reduced to LE-4. If the symptoms (S) indicateneuropathy at LE-3 and damage (Di) is measured at greater than or equalto LE-8, then D may be reduced to LE-5. If the symptoms (S) indicateneuropathy at LE-3 and damage (Di) is measured at greater than or equalto LE-7 and less than LE-8, then D may be reduced to LE-4.

Determining the number of treatments for the treatment plan 404 mayutilize the damage region having the most proximal (e.g., closest to thetorso of the patient) damage when compared to the other body portions,which may be referred to as the “worst damage (D)”. Generally, the moreproximal the damage, the greater the number of treatments, which will beprovided in the output or treatment plan.

For example, as shown in FIG. 11A, if any leg has damage located moreproximal than LE-10 (see FIG. 8 ), then the treatment plan may include17 treatments. If any leg has damage located less proximal than LE-10but more proximal than or equal to LE-7, then the treatment plan mayinclude 15 treatments. If any leg has damage located less proximal thanLE-7 but more proximal than or equal to LE-4 or any arm has damagelocated less proximal than or equal to H-4, the treatment plan mayinclude 12 treatments. If any leg has damage located less proximal thanor equal LE-3 or any arm has damage located less proximal than H-4 butmore proximal than or equal to H-1, then the treatment plan may include10 treatments. If any arm has damage located less proximal than or equalto H-1, then the treatment plan may include 8 treatments.

Determining the amount of time per treatment for the treatment plan 404may utilize the damage region having the most proximal (e.g., closest tothe torso of the patient) damage for each body portion. Generally, themore proximal the damage, the greater the amount of time, which will beprovided in the output or treatment plan.

For example, as shown in FIG. 11A, each leg having damage more proximalthan or equal to LE-4 may be assigned 15 minutes and each leg havingdamage less proximal than or equal to LE-3 may be assigned 10 minutes.Further, each arm having damage more proximal than or equal to A-1 maybe assigned 10 minutes and each arm having damage less proximal than orequal to H-4 is assigned 7.5 minutes. After each of the body portionshas been assigned a time value, the values may be summed to produce atotal amount of time for each treatment of the treatment plan.

The total amount of time for each treatment may be limited for variousreasons, e.g., patient comfort, etc. For example, as shown in FIG. 11A,if both legs are damaged and at least one arm has a damage regiongreater than or equal to A-1 (see FIG. 9 ), then the total amount oftime may be limited to 40 minutes. Further, if both legs are damaged andat least one arm has a damage region less than or equal to H-4, then thetotal amount of time may be limited to 30 minutes.

Another exemplary method of generating a treatment plan for a patient’ssensory impairment may utilize a look-up table (or any other processoraddressable information database) to generate a treatment plan. Forexample, an exemplary table 408 for use in generating a treatment planfor a patient’s sensory impairment is depicted in FIG. 11B.

As described, an exemplary treatment plan may include the number oftreatments and a time value, or amount of time, for each treatment. Thenumber of treatments and the time value for each treatment are, however,merely estimates because the exemplary methods of treating sensoryimpairment described herein may be modified over time depending, e.g.,on the effectiveness of the treatments, subjective patient data,objective measurement data, new treatment techniques, new treatmentapparatus, etc.

Further, an exemplary treatment plan can include exemplary stretchingexercises as well as any other therapy described herein.

After the initial consultation 24 (e.g., in which treatment informationsuch as a treatment plan has been generated 31), one or more treatments26 may be performed on the patient as shown in FIG. 3 . An exemplarymethod of treatment 40 is depicted in FIG. 5 .

Similar to the method of generating a treatment plan 31 shown in FIG. 4, the method of treatment 40 may include collecting subjective patientdata 42. In at least one embodiment of collecting subjective patientdata, a therapist may ask the patient a plurality of questions regardingtheir sensory impairment. For example, a therapist may ask the followingquestions: When did the pain start? Has the pain calmed down? Is thepain radiating? Muscle pain? Exactly where is the pain? When did younotice the numbness or dull feeling? Exactly where is the numbness ordull feeling? Padded, is it feeling thinned out or thicker or is ittight? Do you notice any padded sensations? (e.g., a slight numbnesslike they still have their socks on, or that they are walking on a padof some sort) Does it feel thinned out or thicker or is it tight?Exactly where is the padding, in the toes, ball of foot or heel? Anytingling? When did the tingling increase or decrease, exactly where?When did the burning start? Was this a hot burning sensation or astinging or pins and needles sensation? When did you notice a change inthe burning, if any change? Did you need to cool the burning with wateror was it tolerable? Did the burning increase or decrease later on,e.g., did it first go up and then come down? Exactly where is theburning?

Such subjective patient data 42 may also include restoration symptoms.For example, if nerve activity has increased (e.g., regenerated,restored, etc.), various subjective restoration symptoms may resulttherefrom that are not due to peripheral neuropathy and/or vascularimpairment. More specifically, as nerve activity increases, the use ofvarious tissues such as muscles, joints, ligaments, tendons, etc. mayalso increase (e.g., due to the increase in nerve activity).Consequently, such muscles, joints, ligaments, tendons, etc. may reactto the increase in use resulting in such restoration symptoms. Suchrestoration symptoms may include tightness, soreness, contraction,cramps, pins and needles, buzzing, humming or stinging sensations,tenderness during weight bearing, sharp shooting or zipping sensations,fatigue, and or heavy or wobbly sensations, itching, burning, orfeelings of general fatigue, etc. In at least one embodiment,restoration symptoms may be used to indicate that the patient’s nerveactivity is improving (e.g., peripheral neuropathy is decreasing) evenif other data such as objective measurement data and other subjectivepatient data is not indicating that the patient’s nerve activity isimproving.

Using the answers from such questions, the therapist can enter thesubjective patient data into a computer system (e.g., the computersystem 15 described herein with reference to FIG. 2 ) using a graphicaluser interface similar to the input interfaces 500, 600 of FIGS. 15A-15Dand 16A-16C described herein.

After the subjective patient data has been entered, the method 40 mayadd the subjective patient data 42 into the cumulative patient data 46.The method 40 may then generate treatment information 50 (for an initialor subsequent treatment) using a computer system (e.g., the computersystem 15 described herein with reference to FIG. 2 ) based on at leastthe treatment plan 48 and the cumulative patient data 46. Morespecifically, the treatment information may be generated using analgorithm based on at least presently-collected subjective patient data42, a treatment plan 48 (e.g., generated in an initial consultation 24),and/or cumulative patient data 46 (e.g., if the patient has alreadyundergone a treatment). Cumulative patient data 46 may includesubjective patient data, objective measurement data, evaluation data 27of FIG. 3 , and treatment information determined and/or utilized inprevious treatments or otherwise collected.

The treatment information generated 50 may include at least onetreatment definition for the treatment to be performed on the patient.The treatment definitions may be preset or predefined, e.g., by thealgorithm, or a database or look-up table, and may include one or moretreatment regions of the patient to be exposed to photonic energy totreat one or more body portions of the patient afflicted with sensoryimpairment. Further, the treatment definition may include a time periodof exposure to photonic energy for each of the one or more treatmentregions. A treatment definition, e.g., may be a guide for a therapist todeliver treatment to the patient.

Generally, treatment definitions generated 50 may direct the amount ofexposure time per treatment region and the starting treatment region(e.g., of an extremity) based on the location of the most proximaldamage region. For example, a generated treatment definition may directmore exposure time to one or more distal regions of the body portion ifthe cumulative patient data indicates that the damage is more distal. Inother words, the more distal the damage, the more distal the proportionof total exposure time to photonic energy. Further, a generatedtreatment definition may also direct the starting treatment region(i.e., the region after delivering photonic energy to the root) to amore distal location if the cumulative patient data indicates that thedamage is more distal.

For example, if the cumulative patient data indicates that the damage ismore distal, then the generated treatment region may direct moreexposure time to a patient’s calf than thigh (e.g., at least a greaterproportion of exposure to the patient’s calf than thigh than the lastand/or any other previous treatment).

Exemplary treatment regions are depicted for a leg, an arm, and a backin exemplary treatment displays shown in FIGS. 12-14 , respectively. Thetreatment regions 140 of the leg are labeled A-I. The treatment regions142 of the arm are labeled U-Z. The treatment regions of the backinclude the anatomical locations C6-C8, T1-T2, L1-L5, and S1-S2, locatedin the labeled regions 144.

In at least one embodiment, treatment definitions (e.g., generated for atreatment of a patient during an appointment) may be defined in terms oftreatment phases for each different body portion (e.g., leg, arm, etc.).A treatment phase may include one or more treatment regions of thepatient to be exposed to photonic energy and a proportion of the totaltime period of exposure to photonic energy for each of the one or moretreatment regions in the particular body portion (e.g., leg). Forexample, the proportion of the total time period of exposure to photonicenergy may be a ratio of how much of the total time spent on eachparticular treatment region (e.g., if the total time is ten minutes andthe treatment phase instructs 1/10 of the total time is to be spent ontreatment region A, 1 minute would be spent on treatment region A).Generally, a treatment phase for each body portion may be determinedbased on the most proximal (e.g., closest to the torso of the patient)damage (see damage regions for a patient’s leg, arm, and foot in FIGS.8-10 , respectively) of each particular body portion (e.g., extremity).

For example, a leg may have nine leg treatment phases and the presenttreatment phase may be determined by the most proximal damage. In atleast one embodiment, the leg treatment phase may be determined by thefollowing: if a leg has damage that is greater than or equal to LE-11,then the first leg treatment phase may be determined; if a leg hasdamage that is equal to LE-10, then the second leg treatment phase maybe determined; if a leg has damage that is less than or equal to LE-9and greater than or equal to LE-8, then the third leg treatment phasemay be determined; if a leg has damage that is less than or equal toLE-7 and greater than or equal to LE-6, then the fourth leg treatmentphase may be determined; if a leg has damage equal to LE-5 a fifth legtreatment phase may be determined; if a leg has damage equal to LE-4 asixth leg treatment phase may be determined; if a leg has damage equalto LE-3 a seventh leg treatment phase may be determined; if a leg hasdamage equal to LE-2 a eighth leg treatment phase may be determined; ifa leg has damage equal to LE-1 a ninth leg treatment phase may bedetermined.

The following is an exemplary list of leg treatment phases. Further, inthe following list of leg phase treatments, it is assumed that the totaltreatment time for both legs, e.g., as defined by a treatment plan, is30 minutes. Also, as described above, the time of energy exposure for apair of extremities may also be different. In other words, the time ofenergy exposure may shift to favor the extremity with the most damage(e.g., if the left leg indicates more sensory impairment, the left legmay get ⅔ of the exposure time while the right leg gets ⅓ of theexposure time). Also, a post-treatment cooling therapy may be used afterany treatment or treatment phases described herein as needed (e.g., onan individual case basis. The post-treatment cooling therapy may utilizeskin cooling apparatus such as the skin cooling systems produced byZIMMER MEDIZIN SYSTEMS. For example, cooling therapy may be used toallow therapists and/or practitioners to increase the power density ofthe photonic energy delivered during treatment while diminishing theprobability of hot burning sensations (or any other sensation or reflex)that may be experienced by a patient following treatment (e.g., thenight of the treatment).

Leg Treatment Phase I: 6 min of photonic energy exposure to the spine(treatment regions L1 - L5, S1, & S2); 4 min/leg (treatment region A) ofphotonic energy exposure to the leg paying special attention to the headof the fibula; 4 min/leg (treatment region B) of photonic energyexposure to the thigh, paying special attention to the popliteal fossa;and 4 min/leg (treatment region G) of photonic energy exposure to thefoot, making sure to get in between the toes and around the inferiorportion of the malleoli.

Leg Treatment Phase II: 6 min of photonic energy exposure to the spine(treatment regions L2 - L5, S1, & S2); 2 min/leg (treatment region A) ofphotonic energy exposure at each popliteal fossa and heads of fibula; 5min/leg (treatment region B) of photonic energy exposure for each leg tothe ankle; and 5 min/leg (treatment region G) of photonic energyexposure to each foot, making sure to get in between the toes and aroundthe inferior portion of the malleoli.

Leg Treatment Phase III: 6 min of photonic energy exposure to the spine(treatment regions L3 - L5, S1, & S2); 3 min/leg (treatment region C) ofphotonic energy exposure to the popliteal fossa, the head of fibula, andthe knee; 4 min/leg (treatment region B) of photonic energy exposurefrom the bottom of the knee to the ankle; 5 min/leg of photonic energyexposure (treatment region G); and a remainder of photonic energyexposure time on each foot, making sure to get in between the toes andaround the inferior portion of the malleoli (paying special attention toareas that may still be symptomatic).

Leg Treatment Phase IV: 6 min of photonic energy exposure to the spine(treatment regions L3 - L5, S1, & S2); 4 min/leg (treatment region D) ofphotonic energy exposure to 2/3rds of the shin to ankle; 8 min/leg(treatment region G) of photonic energy exposure; and a remainder ofphotonic energy exposure time on each foot, making sure to get inbetween the toes and around the inferior portion of the malleoli (payingspecial attention to areas that may still be symptomatic).

Leg Treatment Phase V: 6 min of photonic energy exposure to the spine(treatment regions L3 - L5, S1, & S2); 4 min/leg (treatment region E) ofphotonic energy exposure to from the mid shin to the ankle; 8 min/leg(treatment region G) of photonic energy exposure; and a remainder ofphotonic energy exposure time on each foot, making sure to get inbetween the toes and around the inferior portion of the malleoli (payingspecial attention to areas that may still be symptomatic).

Leg Treatment Phase VI: 6 min of photonic energy exposure to the spine(treatment regions L3 - L5, S1, & S2); 4 min/leg (treatment region F) ofphotonic energy exposure on the bottom ⅓ of the shin; 8 min/leg(treatment region G) of photonic energy exposure; and a remainder ofphotonic energy exposure time on each foot, making sure to get inbetween the toes and around the inferior portion of the malleoli (payingspecial attention to areas that may still be symptomatic).

Leg Treatment Phase VII: 6 min of photonic energy exposure to the spine(treatment regions L3 - L5, S1, & S2); 5 min/leg (treatment region G) ofphotonic energy exposure to symptomatic areas; 8 min/leg (treatmentregion H) of photonic energy exposure; and remainder of photonic energyexposure time on each foot, making sure to get in between the toes andaround the inferior portion of the malleoli (paying special attention toareas that may still be symptomatic).

Leg Treatment Phase VIII: 6 min of photonic energy exposure to the spine(treatment regions L3-L5, S1, & S2); 4 min/leg (treatment region H); 8min/leg (treatment region I) of photonic energy exposure; and aremainder of photonic energy exposure time on each foot, making sure toget in between the toes and around the inferior portion of the malleoli(paying special attention to areas that may still be symptomatic).

Leg Treatment Phase IX: 6 min of photonic energy exposure to the spine(treatment regions L3 - L5, S1, & S2); 12 min/leg (treatment region I)of photonic energy exposure; and a remainder of photonic energy exposuretime on each foot, making sure to get in between the toes and around theinferior portion of the malleoli (paying special attention to areas thatmay still be symptomatic).

Further, for example, an arm may have 5 arm treatment phases and thepresent treatment may be determined by the most proximal damage. In atleast one embodiment, the arm treatment phase may be determined by thefollowing: if an arm has damage greater than or equal to A3, then thefirst phase is determined; if an arm has damage less than or equal to A2and greater than or equal to A1, then the second phase is determined; ifan arm has damage equal to H4, then the third phase is determined; if anarm has damage equal to H3, then the fourth phase is determined; and ifan arm has damage equal to or less than H2, then the fifth phase isdetermined.

The following is an exemplary list of arm treatment phases. Further, inthe following list of arm phase treatments, it is assumed that the totaltreatment time for both arms, e.g., as defined by a treatment plan, is10 minutes. Similar to the leg treatments, post-treatment coolingtherapy may be applied when needed.

Arm Treatment Phase I: 2 min of photonic energy exposure to the spine(treatment regions T1 & C6 - C8); 1 min/arm (treatment region U) ofphotonic energy exposure to the shoulder to the elbow; 1 min/arm(treatment region V) of photonic energy exposure to the elbow to thewrist; and 2 min/arm (treatment region W) of photonic energy exposure tothe wrist to the fingertips.

Arm Treatment Phase II: 2 min of photonic energy exposure to the spine(treatment regions T1 & C6 - C8); 2 min/arm (treatment region V) ofphotonic energy exposure to the elbow to the wrist; and 2 min/arm(treatment region W) of photonic energy exposure to the wrist to thefinger tips.

Arm Treatment Phase IV: 2 min of photonic energy exposure to the spine(treatment regions C6 - C8); 1.5 min/arm (treatment region X) ofphotonic energy exposure to the wrist to the finger tips; and 2.5min/arm (treatment region Y) of photonic energy exposure to the fingers/ finger tips.

Arm Treatment Phase V: 2 min of photonic energy exposure to the spine(treatment regions C6 - C8); 1.5 min/arm (treatment region Y) ofphotonic energy exposure to the wrist to the finger tips; and 2.5min/arm (treatment region Z) of photonic energy exposure to the fingers/ finger tips.

The treatment information generated 50 may also include at least onetreatment definition including a power level of the photonic energy tobe delivered to the one or more treatment regions. The power levels tobe delivered to each of the treatment regions may be generated based onany of the subjective patient data, objective measurement data,cumulative patient data, and/or data plan. Further, a unique ordifferent treatment definition may be determined for each body portion(e.g., extremity) of the patient, e.g., based on the unique or differentdata indicative of damage for each body portion. For example, atreatment definition for a patient’s left leg may have a different powerlevel than a treatment definition for the same patient’s right leg.

In the following example, the power level may be generated based onsubjective patient data-more specifically, a hot burning sensation in anextremity felt the night or day after receiving treatment (although thepatient is not actually burned by the treatment). For example, in thetreatment of a patient’s leg, the starting (e.g., for the firsttreatment) power level of the photonic energy for the treatment regionsof a patient’s back corresponding to the damage regions of the leg maybe 6.75 Watts, unless hot burning in the leg was noted in the subjectivepatient data. If hot burning in the leg was noted in the subjectivepatient data, the starting power level of the photonic energy for thetreatment regions of the patient’s back may be 6.25 Watts. In a similarfashion, the starting power level for the treatment regions of thepatient’s leg may be 5.75 Watts, unless hot burning in the leg was notedin the subjective patient data, and in such hot burning case, thestarting power may be 5.25 Watts. Some patients may get a hot burningsensation as they improve. Decreasing the wattage may slow the efficacyof their care, but this can be left to the practitioner’s discretion.

Further, in the treatment of the patient’s arm, the starting (e.g., forthe first treatment) power level of the photonic energy for thetreatment regions of a patient’s back corresponding to the damageregions of the arm may be 6.75 Watts, unless hot burning in the arm wasnoted in the subjective patient data. If hot burning in the arm wasnoted in the subjective patient data, the starting power level of thephotonic energy for the treatment regions of the patient’s back may be6.25 Watts. In a similar fashion, the starting power level for thetreatment regions of the patient’s arm may be 5.75 Watts, unless hotburning in the arm was noted in the subjective patient data, and in suchhot burning case, the starting power may be 5.25 Watts. Again, somepatients may get a hot burning sensation as they improve. Decreasing thewattage may slow the efficacy of their care, but this can be left to thepractitioner’s discretion.

In subsequent treatments, if hot burning is noted in the subjectivepatient data, the power level may be decreased by ½ Watt for the back,the arms, and the legs (i.e., decreased from the power levels used inthe last treatment). Further, if hot burning is noted in the subjectivepatient data for two consecutive treatments, the power level may bedecreased by 1 Watt for the back, the arms, and the legs (i.e.,decreased from the power levels used in the last treatment). Stillfurther, if hot burning is not noted in the subjective patient data, thepower level may be increased by ½ or 1 Watt for the back and ¼ Watt forthe arms and the legs (i.e., increased from the power levels used in thelast treatment).

After the treatment definition has been generated 50 and beforeproviding therapy to the patient, the method 40 may require apractitioner (e.g., doctor) to approve the treatment definition before atherapist performs the therapy according to the treatment definition. Assuch, the method 40 includes obtaining treatment information approvalfrom a practitioner 52 before allowing the treatment to be performed 54.Obtaining approval 52 may include presenting the practitioner with thetreatment definition as well as any other the treatment information,subjective patient data, objective measurement data, and/or cumulativepatient data such that the practitioner can evaluate the presenttreatment definition.

If the practitioner approves of the treatment definition, the method 40may proceed to performing treatment on the patient as defined by thetreatment definition 54. Further, if the practitioner wishes to modifythe treatment definition, the practitioner may do so prior to approvingtreatment definition 52. In at least one embodiment, this approvalprocess 52 may utilize one or more computer systems operatively coupledto one another such that a practitioner may approve of a treatmentdefinition using a computer system that is remotely located with respectto a therapy system. Such computer systems will be further describedherein with reference to FIGS. 6-7 .

Further, in at least one embodiment, the practitioner may be presentedwith a graphical user interface for approval and/or modification of thetreatment definition.

If the practitioner approves of the treatment definition, the treatmentmay be performed on the patient 54. In at least one embodiment, thetherapy system to be used by the therapist to deliver photonic energymay not be activated (e.g., such that it may not be used to exposetreatment regions of a patient to photonic energy) until the therapysystem receives approval from the practitioner. Further, in at leastanother embodiment, the therapist may not be signaled or notified tobegin the treatment until the practitioner approves the treatmentdefinition.

Further, the therapy apparatus (e.g., therapy system 13 as describedherein with respect to FIG. 2 ) used to deliver photonic energy to thepatient may be controlled by the treatment definition (e.g., generatedby the local system 132 as described herein with reference to FIG. 6 ).In other words, the local system 132 (as described herein with referenceto FIG. 6 ) may control any one or more parameters of the therapyapparatus that delivers photonic energy (e.g., power, time, pulsefrequency, frequency, wavelengths, etc.). For example, if the treatmentdefinition calls for a power level of 6.5 W, then the therapy apparatusmay only output 6.5 W. Still further, the therapy apparatus may alsoinclude a timer that counts down the time remaining for the time periodfor each particular treatment region, and upon expiration of the timeperiod, may indicate to the therapist (e.g., through sound, light, etc.)to move the laser therapy to the next treatment region.

An exemplary graphical user interface 700 to be used by the therapysystem 13 during treatment (e.g., delivery of photonic energy to thepatient under control or controlled by a treatment definition) isdepicted in FIGS. 17A-17D. As shown in FIG. 17A, the graphical userinterface 700 depicts a portion of a human body 702, e.g., a portionthat shows the treatment region for the present step and identification704 of the treatment region on the portion of a human body 702. As show,the identification 704 includes an outline of the treatment region. Inat least one embodiment, the identification 704 may include“highlighting” of the treatment region on the portion of a human body702. As such, a therapist may view the interface 700 to determine wherethe photonic energy should be delivered to the patient.

The interface 700 may further depict a time period of exposure 706 forthe treatment region to be exposed to photonic energy using atherapeutic laser. The time period of exposure 706 may decrement, ordecrease, in response to the therapist delivering photonic energy usingthe therapy apparatus. For example, the therapist may have to depress abutton, or flip a switch, to deliver photonic energy using a therapeuticlaser, and the time period of exposure 706 may decrease, or “countdown,” when the button is depressed, or the switch is flipped. Theinterface 700 may further indicate to the therapist when the time periodfor exposure 706 has finished such that the therapist may move to thenext step, e.g., as shown in FIG. 17B. The interface 700 may furtherdepict a power value 708 of the photonic energy to be delivered to thetreatment region 704.

As provided by a treatment definition, the interface 700 may depicttreatment processes that include delivery of photonic energy to selectedtissue in proximity to a selected nerve root, e.g., as shown in FIGS.17A-17B, and delivery of photonic energy to selected tissue of anaffected extremity in proximity to a nerve extending from the selectednerve root, e.g., as shown in FIGS. 17C-17D. More specifically, as shownin FIGS. 17A-17B, the interface 700 directs therapy to be delivered tothe selected tissue in proximity to a selected nerve root, e.g., spinalregion L3-S2 and C6-T1, and as shown in FIGS. 17C-17D, the interface 700directs therapy to be delivered to the selected tissue of the affectedextremity in proximity to a nerve extending from the selected nerveroot, e.g., the surface of the arm and the surface of the hand.

Although the exemplary interface 700 shown in FIGS. 17A-17D depicts aback and arm for delivery of therapy, the interface 700 may depict anyportion of a human body, e.g., leg, hands, feet, etc. After thetreatment has been completed, an interface may be displayed to thetherapist showing each of the therapy steps that were completed.

The therapy apparatus as described herein with reference to FIG. 2 mayinclude laser treatment apparatus. In at least one embodiment, the lasertreatment apparatus may include a button that, when actuated, deliversphotonic energy through, e.g., a wand. In the exemplary therapyapparatus that has a timer, the timer may only “count” or “run” when thebutton is actuated such that, e.g., the therapist delivers photonicenergy for the full amount of time as instructed by the therapyapparatus, per treatment definition.

For one or more reasons, the method 40 may determine that the patientshould be retested 56 and that the practitioner should collect objectivemeasurement data from the patient 58. Such retesting may be one way thatthe treatment definition may substantially change, e.g., change atreatment phase, such as moving from treatment phase I to treatmentphase II on a leg.

In at least one embodiment, if the newly-generated treatment definitionhas changed by a certain quantifiable amount from the treatmentdefinition of the last treatment (e.g., subjective increase or decreaseof symptoms), then it may be determined that the patient be retested 56.For example, if subjective patient data collected during the presenttreatment appointment indicates that at least one region of one or moreof the patient’s body portions has had a 30% or greater change in pain(or another sensation), then it may be determined that the patient beretested 56. Further, for example, if the subjective patent dataindicates either an increase or decrease of 30% or a substantialdecrease in symptomatic surface area, then it may be determined that thepatient be retested 56.

Further, in at least one embodiment, the treatment plan may specificallyschedule retests (e.g., one or more retests) to occur over the course ofthe treatment plan. For example, in a treatment plan having 15treatments, a retest may be schedule for the 3^(rd), 8^(th), and 12^(th)treatment. Further, a retest may be scheduled during the finaltreatment. As such, if it is determined that the treatment plan hasscheduled a retest on a particular treatment, then it may be determinedthat the patient be retested 56.

Further, as shown in FIG. 5 , the new objective measurement datacollected 58 after determining to retest 56 may be inputted into thecumulative patient data 46 such that it may be used in the generation oftreatment information 50 during the next treatment appointment. In atleast one embodiment (not shown), the retest may take place prior to thepresent treatment such that the treatment definition may be modifiedaccording to the newly-collected objective measurement data prior to thepresent treatment.

If, during the retesting, the practitioner determines from the objectivemeasurement data that no body portions have any damage regionsremaining, the treatment may be complete, and any additional treatmentmay be maintenance or follow-up treatments. For example, as shown inFIG. 3 , after the treatments 26 have been completed, the method 22continues to follow-up/maintenance treatments 28, which may includeregularly scheduled treatments to maintain the health of the patient(e.g., to inhibit sensory impairment from reappearing).

Further, a patient may have symptoms even after objective measurementdata indicates success (e.g., if areas of pinprick/vibration have beenrestored). Areas indicative of damage, or past damage, may be used as anindication of where the damage has gotten to, as well as an indicationof which areas are responding. Also, any symptoms, or subjective patientdata, may be collected and used to determine, or to generate, treatmentinformation to be used to treat a patient. In at least one embodiment,the additional symptoms, or subjective patient data, may be enteredusing any of the graphical user interfaces (e.g., interface 500 shown inFIGS. 16A-16C) and/or systems described herein.

Follow-up/maintenance treatments 28 may be automatically scheduled 1month to 6 months after the treatments 26 have been completed. Further,additional follow-up/maintenance treatments may be scheduled in thefuture based on a determined frequency of treatments that inhibits thereassurance of sensory impairment.

For example, maintenance appointments may be initially scheduled everytwo months. If the area of sensory loss/impairment is at the ankle orthe mid-foot, then the maintenance appointment frequency (e.g., the timeperiod between appointments) may be maintained. If the area of sensoryloss/impairment is below the mid-foot and the patient is comfortable,then the time period between maintenance appointments may be decreasedby about 2 to about 4 weeks. If the area of sensory loss/impairment isabove the ankle, then then the time period between maintenanceappointments may be increased by about 1 to about 2 weeks. Further, if apatient skips or misses a maintenance appointment, another maintenanceappointment may be scheduled in about 1 to about 2 weeks.

In each follow-up/maintenance treatment 28, subjective patient data andobjective measurement data may be collected and entered into a computersystem for record-keeping and the generation of a treatment definitionfor treatment, if needed.

Further, at any time with general method 22 of FIG. 3 , one or morefurther evaluations 27 may be conducted to, e.g., establish a generalaggregate appraisal of the patient’s sensory neuropathy. The one or moreevaluations may include the collection of subjective patient and/orobjective measurement data and may utilize a modified Total NeuropathyScore, a Balance Screening Test, and/or one or more Quality of Lifetests.

Each of the Modified Total Neuropathy Score (mTNS), the BalanceScreening Tool (BST), and the Neuro-QOL can be administered at the startof treatment, the end of treatment, 3 months post treatment, and every 6months after that. The scores may be added to the multi-variant measuresto more accurately assess long term results of treatment and inimproving the treatment modalities at initial treatment and as part ofmaintenance treatments. The following references include articles usingthese tools to rate patients with neuropathy symptoms:http://www.supportiveoncology.net/journal/articles/0408w09.pdf andhttp://www.ncbi.nlm.nih.gov/pubmed/20357656. The Modified TotalNeuropathy Score measures sensory symptoms, motor symptoms, neurologicalexam motor and reflex scores.

A balance test can be used in the methods of the present disclosure. Anexemplary balance test is described, for example, athttp://ijahsp.nova.edu/articles/vol5num4/pdf/langley.pdf.http://www.ijtr.co.uk/cgi-bin/go.pl/library/article.cgi?uid=22472;article=IJTR_13_12_558_561.This test has been validated with the “gold standard” tool for balancein an elderly population with is the Berg Balance Test. The actual testand how to administer and score it are further described in the ExamplesSection.

The Neuro-QOL Test has several short screening tools as part of theintake process from which the practitioner can select. The tool isdescribed further at http://www.mss.northwestern.edu/faculty/cella.htmland http://www.neuroqol.org/Web%20Pages/Neuro-Qol%20Team.aspx.

During patient consultations, it may be useful to graphically depict theprogress of the treatment. As such, the exemplary methods and systemsdescribed herein may further include graphical user interfaces, as shownin FIGS. 18A-18B, for display of various historical data, e.g.,regarding the subjective patient data, objective measurement data,treatment information (e.g., including treatment definitions, performedtreatments, etc.), and/or any other information collected, or gathered,over the course of therapy. For example, any progress may be shown bydisplaying subjective patient data (or any other data such as objectivemeasurement data) recorded during the initial consultation (or any othertreatment) next to subjective patient data (or any other data such asobjective measurement data) recording during a subsequent treatment.

As shown in FIGS. 18A-18B, a first body portion 902 and a second bodyportion 904 are depicted in exemplary interface 900. Different damageregions 906 may be identified on each body portion 902, 904 similar tothe objective/subjective patient data input interfaces described herein(e.g., each damage region may have one or more icons representing theone or more sensation and the one or more values associated with eachsensation). The one or more sensations and values indicated by icons onthe second body portion 904 may be representative of the sensoryimpairment measured, or recorded, during an initial consultation (e.g.,before receiving any therapy). The one or more sensations and valuesindicated by icons on the first body portion 902 may be representativeof the sensory impairment measured, or recorded, during a consultationselectable using dialog 908.

For example, as shown in FIG. 18A, the sensations and values fromobjective measurement data indicated on the first body portion 902 arerepresentative of the sensory impairment measured during the initialconsultation, and as a result, mirror the second body portion 904. Asshown in FIG. 18B, if a user selects a treatment using the dialog 908,the icons representing the sensations and values on first body portion902 will change to that which were measured during the selectedtreatment (e.g., the 3/12 treatment). As can be seen by comparing thefirst body portion 902 and the second body portion 904, this exemplarypatient has shown an improvement in sensory impairment from the initialconsultation to the 3/12 treatment performed on Jun. 21, 2011.

In other words, interface 900 provides a side-by-side comparison of theprogression of the treatment of a patient’s sensory impairment, whichmay be useful in showing a patient the effectiveness of the treatment.The interface 900 may be further used with other body portions, such asa foot, an arm, and/or any other body portion contemplated.

As described herein, exemplary methods for use in treating a patientsensory impairment may utilize one or more computer systems. Anexemplary enterprise system 100, including a plurality of computersystems, that may be used in the implementation of one or more exemplarymethods described herein is depicted in FIG. 6 .

The enterprise system 100 includes a management system 120 and one ormore local systems 130A, ... 130 n. The management system 120 (e.g.,which may be a central hub system for the local systems 130) and thelocal systems 130 are operatively coupled (e.g., through a networkingconnection over the Internet) such that they may exchange informationwith respect to the facilitation of providing systems and methods forthe treatment of sensory impairment. Further, the management system 120may install software updates to the local systems 130, e.g., to updatetreatment algorithms, etc. Still further, the management system 120 andthe local systems 130 may exchange financial information, e.g.,calculate licensing fees, process insurance information, etc.

The management system 120 may be capable of receiving all or portions ofthe subjective patient data, objective measurement data, treatmentinformation, etc. recorded or entered into each of the local systems 130to generate a dataset of all the patients being treated by the system100. The management system 120 may utilize such data to generate and/ormodify one or more treatment algorithms, e.g., tailored to treatspecific symptoms, etc. The management system 120 may further be capableof transmitting the new and/or improved algorithms to each of the localsystems 130.

In at least one embodiment, the management system 120 may be designed togroup similar patients and track and assess their symptom improvement inacute care (e.g., over 3-6 weeks) and/or symptom improvement in lifelongfollow-up care. Further, the management system 120 may iteratively testvarious parameters of the therapeutic laser being used by therapysystems to assess the parameters being used (e.g., evaluate eachparameter’s importance in the acute treatment of a patient symptomsand/or the long term effectiveness of the treatment). For example, themanagement system 120 may use different treatment algorithms/protocolsto generate various treatment settings to be used by various localsystems. The effects of the various treatment settings may be comparedto determine their effectiveness (e.g., one or more parameters orsettings used with the therapeutic laser may be analyzed in view of theeffectiveness as shown through collected subjective patient data andobjective measurement data). In at least one embodiment, the managementsystem 120 may identify certain groups of peripheral neuropathy patientsthat respond to a particular course of treatment.

Further, the management system 120 may coordinate and conductdouble-blind and placebo testing on small or large groups of patientsand on individual patients (e.g., to treat one leg with the laser andthe other with placebo) by transmitting various treatment algorithms(e.g., for use in generating treatment information) to one or morelocals systems 130. As described herein, the management system, whichmay effectively be a centralized control system, may have the ability todownload all information with respect to every patient being treated byany of the one or more local systems 130. Such information may includeall or portions of the subjective patient data, objective measurementdata, treatment information (e.g., operating parameters of the laser,number of treatments, duration of treatments, and/or frequency oftreatments, etc.), any treatment definition or protocol changes (e.g.,made by a doctor, etc.). The ability to conduct double-blind and placebotesting may also reside in each local system 130, e.g., with the abilityto edit and define each treatment protocol for each individual patient.

A wide range of objective and subjective measurements may be used toaccess and to track a patient’s peripheral neuropathy symptom status. Ata high level, the length of time a patient has had peripheralneuropathy, the ideology, which may be broken into categories such asmetabolic, idiopathic, toxic, trauma, autoimmune, infection, hereditary,etc., and any drugs the patient has been taking may be tracked. Thisinformation may allow (e.g., the management system 120) to assess ifthere are certain types of peripheral neuropathy that can and should betreated differently and if some respond better than others.

Further, the subjective patient data recorded and tracked over timeusing the systems and methods described herein includes the patientsperception of pain, tingling, numbness, tightness and burning (e.g.,heat) on any extremity broken down in discrete damage regions (e.g.,eleven different damage regions on legs, eight different damage regionson the arms). This subjective data is survey data and may be measuredevery treatment. In addition, the objective measurement data may includeobjective assessments of pinprick and vibration of the same damageregions of the affected extremities, which may be measured duringobjective measurement exams that may be completed at least 4 timesduring the course of acute care and during any follow-up care. Also, themethods and systems described herein may further collect data usingthree higher level exams from the beginning of acute care through theend of acute care, and then every 6 months for the lifetime of care.Such high level tests may be the Modified Total Neuropathy Score, BSTBalance Test, and a series of Quality of Life Assessments for thevarious areas (e.g., stigma, sleep disturbance, upper extremityfunction, lower extremity function, satisfaction with social roles andactivities, ability to participate in social roles and activities,fatigue, etc.).

Using the management system 120, such data may be analyzed toiteratively test various laser settings to see which improves acute care(e.g., symptom relief) for the various types of peripheral neuropathy,with the goal to develop the optimal acute laser treatment for each typeof peripheral neuropathy. Further, the data may be analyzed to assesslong term effectiveness for the above and assess how the variousperipheral neuropathy drugs affect care acutely and in the long term.

Further, the methods and systems described herein for tracking andanalyzing data including subjective patient data, objective measurementdata, supplemental data (e.g., drug information, etc.) and/or treatmentinformation may be used on diseases/conditions other than peripheralneuropathy In other words, the methods and systems described hereincould be replicated for other diseases and/or other therapeutic toolswhere a multivariate iterative approach can be used to achieve optimalresults.

In at least one embodiment, the management system 120 may providedifferent treatment algorithms to different local systems 130 such thateach local system 130 may test a different treatment algorithm, therebygenerating more unique data. The management system 120 may utilize suchdata to generate or modify one or more treatment algorithms, e.g.,tailored to treat specific symptoms, etc.

Further, the management system 120 may be capable of enabling ordisabling one or more local systems 130 (e.g., to disable therapysystems, etc.) for various reasons (e.g., not providing data, failure topay license fee, etc.).

Each local system 130 may also be operatively coupled to one or morepractitioner systems 132A, ... 132 n, one or more therapy systems 134A,... 134 n, and one or more patient input systems 136A, ... 136 n, andoperate independently from one another (e.g., one local system does notinteract or share data with another local system). The local system 130may be substantially similar to the computer system 15 described hereinwith respect to FIG. 2 . For example, the local system 130 may beconfigured to receive input such as, e.g., subjective patient data,objective measurement data, etc., and further configured to generate anoutput such as treatment information including treatment plans andtreatment definitions. Further, the local system 130 may be configuredto operate as the central hub for the practitioner systems 132, therapysystem 134, and the patient input systems 136 such that it may exchangeor broker information between such systems as well as act as datarepository.

Each therapy site may include at least one of the therapy systems 134.An exemplary therapy system 134 is further depicted in FIG. 7 . Thetherapy system 134 includes input apparatus 150, display apparatus 152,laser treatment apparatus 154, skin cooling apparatus (e.g., the skincooling systems produced by Zimmer MedizinSystems) (not shown), andcomputing apparatus 156, each of which may be operatively coupled to oneanother to interoperate. The input apparatus 150 may be any apparatuscapable of entering subjective patient data and objective measurementdata into the therapy system 134 such as, e.g., a keyboard, atouchscreen, a scanner, a disk drive, a universal serial port, etc. Thedisplay apparatus 152 may be any apparatus capable of displayingtreatment definitions, graphical user interfaces for the entering ofdata, etc. such as, e.g., a liquid crystal display, touchscreen, etc.The laser treatment apparatus 154 may include any apparatus capable ofdelivering photonic energy at a power of at least 6.5 Watts such as,e.g., a K-LASER 1200 produced BY K-LASER USA of Franklin, Tennessee, aLCT-1000® DEEP TISSUE THERAPY LASER produced by LITECURE, LLC of Newark,Delaware, and a AVICENNA AVI HPLL-12 laser produced by AVICENNA LASERTECHNOLOGY, INC. of West Palm Beach, Florida, etc. The processingapparatus 156 may be substantially similar to processing apparatus 16described herein with respect to FIG. 2 .

The therapy systems 134 may be operatively coupled (e.g., through anetwork connection locally or through the Internet) to the local system130 such that subjective patient data and/or objective measurement datamay be transmitted from the therapy systems 134 and received by thelocal system 130 and treatment information may be transmitted from thelocal system 130 and received by the therapy systems 134. Further, thelocal system 130 may also transmit information to the therapy systems134 to control to the therapy systems 134, e.g., to block the therapysystems 134 from delivering photonic energy until practitioner approvalof a treatment definition is received, etc.

The practitioner systems 132 may be configured to provide anypractitioner-related functionality within the exemplary methodsdescribed herein. For example, the practitioner systems 132 may beconfigured to receive and modify treatment definitions, to enter orrecord objective measurement data, to allow approval of treatmentdefinitions, and to transmit approval messages, treatment definitions(e.g., including modifications), and objective measurement data to thelocal system 130. In at least one embodiment, the practitioner system132 may be a tablet computer, e.g., an APPLE IPAD.

The patient input systems 136 may be configured to provide anypatient-input-related functionality within the exemplary methodsdescribed herein. For example, the patient input systems 136 may beconfigured to enter or record subjective patient data and to transmitsuch subjective measurement data to the local system 130A. In at leastone embodiment, the patient-input system 136 may be a tablet computer,e.g., an APPLE IPAD.

In other words, the exemplary methods and systems disclosed herein mayprovide a unified framework of diagnostic parameters that allow thepractitioner to objectively quantify differential diagnosis (e.g., bycomputerized differential diagnosis) in the evaluation and treatment ofsensory impairment, e.g., that associated with peripheral neuropathy.That is, while not being bound to any particular scientific theory, thepresent disclosure provides an internally consistent framework uponwhich the practitioner can ascertain and develop scientific measurementsthat can be used in treatment methods.

For example, in one embodiment, the diagnostic tools disclosed hereinprovides the practitioner with an internally consistent method forsystematically collecting data (e.g., objective measurement data and/orsubjective patient data) about a medical condition, reducing that datato one or more sets of variables, developing and establishingcorrelations among and between these variables, and using suchcorrelations to select or establish one or more treatment parameters ofa treatment definition. The practitioner then may use this treatmentdefinition to deliver treatment to the patient in a methodicalprogressive fashion.

Once a patient has been the subject of one or more treatments, thepractitioner may then ascertain the condition of the patient once againand collect more data about the patient’s condition, including, but notlimited to, collecting another set of data in the same manner as doneprior to the treatment. Thus, the practitioner iterates the datacollection, makes a correlation among or within the data, establishesanother treatment definition using the exemplary methods and systems tobe used within a single treatment, and provides this selected treatmentto the patient. The data that can be collected can include, for example,sensations (e.g., pain, tingling, numbness, burning, heat), quality ofthe sensation (e.g., shooting pain, dull or padded feelings ofnumbness), level of the sensation (e.g., pain on a scale of 0-10), andwhether the sensation is increased or lessened since the last visit. Inaddition to these and other variables, discussed herein, one variablethat can be iterated is the time between each treatment.

Thus, it can be seen by the following non-limiting examples, that thepractitioner can use an internally consistent set of scientificobservations and measurements to determine treatment information (e.g.,to be used in treatment), and determine the efficacy and efficiency ofthe one or more treatments so as to, e.g., improve the algorithm togenerate such treatment information. Thus, differential medicaldiagnoses can be made using the techniques described herein.

In this context, the term “treatment efficacy” is used to capture theextent of which a particular treatment has been able to modify theunderlying condition for which treatment has been established.“Treatment efficiency” is used to capture the effect of each treatmentand determine how many individual treatment cycles are to be performedand/or whether the cost/benefit balance for the patient makes subsequenttreatment cycles worthwhile to a patient. Worthwhile treatments aresubjective and include consideration of the extent to which a patient’ssymptoms and/or condition have been improved.

Representative parameters and parametric data that can be used by thepractitioner in establishing a treatment definition for treatment ofperipheral neuropathy (of any origin or type) using, e.g., therapeuticclass IV lasers.

For example, in the treatment of peripheral neuropathy affecting the legor legs, the practitioner may measure the pattern of perceived painalong the lumbar and legs. These measurements can include whether or nota Bibinski reflex is present or absent in one or both legs and whetheror not the reflex is normal (n) or abnormal (ab), for example. Oncemeasured, the practitioner can assign a value to this variable (e.g., avariable that could be labeled “BR” for Babinski reflex, right side and“BL” for Babinski reflex, left side). This value could be labeledpositive (plus) if the reflex is present and negative (minus) if thereflex is absent. If the reflex is normal, the value that can beassigned is “0”. If the reflex is abnormal or atypical, the value thatcan be assigned is “1”. Thus, reduced to mathematical terms, the abovedata may be represented as follows: BR = {+0, -0, +1, -1}; BL = {+0, -0,+1, -1}. This representation is exemplary only and is not intended to belimiting.

Another exemplary value that may be used to assist in diagnosis andtreatment development is the Wartenberg Pinwheel test that is used forsensory evaluation along the dermatomal axis. In this test, a metalpinwheel may be rolled over the skin to permit establishment of locationof whether or not a patient perceives the location of the pinwheel andif the sensation is perceived as greater at any particular region. Forexample, a diagnostic instrument known as a Wartenberg Pinwheel isrolled over a patient’s skin along a nerve’s, or multiple nerves’,dermatomes. The distance from a particular nerve root is measured. To,capture this data, a variable such as PWP-R (Pinwheel test, sensoryperception, right axis) will measure the distance from a right sidenerve root to the onset of perception of the pinwheel rolling along theskin. Thus, for example, reduced to mathematical terms, if a patientperceives the pinwheel at a location along the dermatome at a distanceof 60 centimeters (cm) from the nerve root, the data would berepresented as PWP-R = 60 centimeters. Additionally, to permitcomparison between sets of data collected from different patients, theterm PWP-R may be expressed as a ratio using the parameter variablePWRP-R (pinwheel, relative data, perception, right side) as PWRP-R = 60cm /100 cm, where 60 cm is the position of the location of perceptionrelative to a nerve root and 100 is the distance from the nerve root tothe end of the big toe. Thus, the relative value of PWRP-R = 0.6. Thisdetermination of the mathematical representation of PWRP-R as onerelative value further provides an example of inter-data analysis. Thisrepresentation is exemplary only and is not intended to be limiting.

The Wartenberg Pinwheel test can also be used to detect locations ofhypersensitive perception. In this test, a metal pinwheel may be rolledover the skin to permit establishment of location of whether or not apatient perceives a sensation that is greater at any particular locationa nerve’s, or multiple nerves’, dermatomes. As noted above, a diagnosticinstrument known as a Wartenberg Pinwheel is rolled over a patient’sskin along a nerve’s, or multiple nerves’, dermatomes. The distance froma particular nerve root is measured. To, capture this data, a variablesuch as PWHS-L, (Pinwheel test, hypersensitive perception, left axis)will measure the distance from a right side nerve root to the onset ofperception of the pinwheel rolling along the skin. Thus, for example,reduced to mathematical terms, if a patient perceives the pinwheel at alocation along the dermatome at a distance of 60 centimeters (cm) fromthe nerve root, the data would be represented as PWHS-L = 60centimeters. Alternatively, to permit comparison between sets of datacollected from different patients, the term PWHS-L may be expressed as aratio using the parameter variable PWRHS-L (pinwheel, relative data,perception, right side) as follows PWRHS-L = 60 cm/100 cm, where 60 cmis the position of the location of perception relative to a nerve rootand 100 is the distance from the nerve root to the end of the big toe.Thus, the relative value of PWRHS-L = 0.6. The determination of themathematical representation of PWRHS-L as one relative value furtherprovides an example of inter-data analysis. Again, this representationis exemplary only and is not intended to be limiting.

It is noted that any test of neural function may be used. Further, testsmay be performed anywhere in or on the body as long as they arereproducible and the practitioner is able to convert their observationsto some value of some variable. Applying this concept to the PinwheelTest above, the practitioner could define another variable as "N-PWP"(non-dermatomal), where perception of a pinwheel placed at any locationof the body other than along a particular dermatomal nerve axis ofinterest. Thus, when testing peripheral nerve function along the arm,the practitioner could first test patient perception along the axis ofthe radial nerve and capture the response using any consistent metric.This metric could then be assigned to the variable N-PWP. In order todistinguish data obtained from bilaterally symmetric anatomy, theaddition of a descriptor to a variable is appropriate. Thus, incapturing a perception response to a pinwheel placed in non-dermatomalareas of the right arm, a suitable variable includes N-PWP-R. Similarly,where the data captured relates to assessing non-dermatomal areas ofhypersensitivity with the Pinwheel Test, a variable such as N-PWHS-Rcould be used.

Other measures of neurological function, for example, known to thepractitioner include: Vibrating Tuning Fork Test; Tinel’s Test; PinprickTest; Visual color observation; Temperature; balance; gait. Thus, forexample, following patient examination, a multivariate data set can becaptured, which could be represented as follows:

Patient X: BR=+1, BL=+0, N-PWP-R=.7,N- PWP-L=.5, N-TFR=.8, N-TFL=.5,G=U, SCF=pale, wherein: BR is right sided Babinski’s reflex; BL is leftsided Babinski’s reflex; N-PWP-R is non-relative right side Pinwheelperception test; N- PWP-L is non-relative left side Pinwheel perceptiontest; N-TFR is non-relative right side Tuning Fork test; N-TFL isnon-relative left side Tuning for Test; G is a clinically defined gaittype; SCF-R is defined scale for capturing the color of the right foot.

For subjective patient data, data values may be assigned to a data valueset such as that illustrated above for the Babinski Test. Thus, whenmeasuring temperature, data values may be either metric (for example,degrees centigrade) or subjective (for example, W-warm, N-neutral,C-cold). For tests that have a limited value range such as reflexes thatpresent or absent, values such as “+” (positive) and “-” (negative) maybe used.

Although descriptive variable annotation assignment has an advantage ofproviding mnemonic cues, any variable naming scheme could be employed,as long as all practitioners use the same scheme and collect data insimilar ways. Such consistency provides the advantage that data can becompared. For example, data obtained from different patients (by thesame or different practitioners) can be collected over time. Aconsistently defined data collection scheme coupled with consistentapparatus of measurement and assignment of values to variables alsoprovides the ability to perform mathematical (e.g., statistical)analyses. Further, the use of an internally consistent scheme for datacapture provides the ability to correlate treatment modalities withtreatment outcomes.

A wide variety of sets of data can be visualized using any mathematicaltools. For example, “primary data” represents the data as it isinitially captured such as the distance along a dermatomal axis that apatient perceives a stimulus. “Secondary data” is the result ofprocessing primary data using any means such as mathematical means toperform correlations within and between sets of data or graphs resultingfrom plotting data by any means available the practitioner. When usingtools that assist the practitioner in using primary data to assign andevaluate treatment plans, the practitioner may graph results, usetables, assign variable to sets of data, or use secondary data such ascorrelation coefficients. Data can be collected by any means known tothe practitioner, including memory, paper, and/or electronic means,using, for example, diagrams of the body sectioned as shown herein,e.g., in FIGS. 8-10 .

The multitude of potential measurements can include an indefinite numberof parameters including those well known in the medical community, aswell as those to be developed by a practitioner. Regardless of themeasurement, using the examples and guidance contained herein, thepractitioner can reduce data to parameters and parametrics.

To aid the practitioner in detection, appreciation, and utilization ofdata, the information contained in the data can be analyzed by using anymathematical and/or statistical visualization tool. For example, pleasesee the following for exemplary analysis methods and/or systems that maybe used with the exemplary methods and/or systems disclosed herein:http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.103.528&rep=repl&type=pdf,

Further, the following provides Fourier and Calculi for doing lineprojections; very amenable to computer based visualization of paireddatasets:http://www.ifs.tuwien.ac.at/~mlanzenberger/teaching/ps/ws04/stuff/auth/00146402.pdf.

Practical applications: The Andrews curves set/plot and the Fractal Foampermit direct visualizations of data optima; especially where nodes andpeaks are expected. This latter might be applicable to selection oftarget anatomy and treatment parameters.

Still further, the following reviews different methods for visualizingcomplex data sets:http://home.comcast.net/~patrick.hoffman/viz/MIV-datamining. Moreparticularly, parameters and parametrics from one patient’s datacollection can be used in comparisons and mathematical analysesacross/among numerous patients, including the response of differentpatients to similar or dissimilar treatments, as well as the efficacyand efficiency of such treatments. Thus, the instant methods include theuse of inter patient analyses to establish and standardize new treatmentparameters as well to optimize treatment outcome efficiency andefficacy. A continual diagnosis, treatment optimization, and treatmentefficacy/efficiency feedback loop may be established to continuallyoptimize patient treatment methods.

EXAMPLES

Objects and advantages of this disclosure are further illustrated by thefollowing examples, but the particular materials and amounts thereofrecited in these examples, as well as other conditions and details,should not be construed to unduly limit this disclosure.

Exemplary Stretching Exercises

To carry out toe stretch up (1): cross right leg over left knee; grasptoes and pull upward; hold for 1 minute; repeat using other foot.

To carry out toe stretch down (2): cross left leg over right knee; placeright thumb on ball of left foot, and push up towards the top of thefoot; use the rest of the fingers to wrap the toes around the thumb;hold for 1 minute; repeat using other foot.

Stretch (3) foot mobilization is carried out as follows: grasp themetatarsal phalangeal joint area above the big toe on left foot betweenthumb and forefinger of left hand; grasp adjoining toe bone betweenthumb and forefinger of right hand (note that the fingers are not on thetoe, but above the toe area as shown in foot bone illustrations to rightof exercise drawings); move toe bones up and down in alternatedirections a total of 10 times; shift hand position down foot, and movetoe bones up and down in alternate directions; shift hand position down,repeating up and down hand movements; shift hand position down to finalposition, with right hand on pinky bone and left hand on adjoining toebone; repeat up and down hand movements; work back up foot, toward bigtoe; repeat, going up and down left foot again; repeat entire exerciseusing other foot.

Straight ankle stretch (4) is carried out as follows: cross right legover left knee; place left hand over right foot; gently pull your foottoward yourself until you feel a stretch; hold for 1 minute; repeat forother ankle.

To carry out ankle stretch up (5): cross right leg over left knee; placeleft hand over right foot; gently pull your foot towards you as perstretch 4 as well as upward towards the ceiling until you feel astretch; hold for 1 minute; repeat for other ankle.

To carry out ankle stretch down (6): cross right leg over left knee;place left hand over right foot; gently pull your foot toward you (asper stretch (4)) as well as toward the floor until you feel a stretch;hold for 1 minute; repeat for other ankle.

To carry out stretches (4), (5), and (6) with an alternative ankleposition, sit with your leg bent in front of you; place one hand on yourlower leg for stability and grasp your foot near your toes with theother hand.

To carry out shin stretch (7): sit with your knees bent and place onefoot flat on the floor under a couch or cabinet; tuck your other footunder elevated leg in a comfortable position; using the edge of thecouch or cabinet as leverage, slowly slide backwards on your bottomuntil you feel a gentle stretch in the front of your leg and foot; holdstretch position for 1 minute; repeat using other leg. Alternatively, alow rolling chair or stool can be used if the patient has difficultygetting up from the ground.

PATIENT 1 Case Study

Chief Complaint: Patient is a 79 year old male; complaints of bilateralnumbness/paresthesia, pain, shooting pains, hypersensitivity, and pinsand needles bilaterally distal to the knees.

Cause of Neuropathy: Unknown.

Progression of symptoms and present symptoms: Patient stated that hebecame aware of the symptoms approximately a little over a year ago.Patient reported the symptoms started in the toes and progressedproximally and severity of symptoms increased over time. Upon intake,patient was symptomatic bilaterally toes to knees. Patient rated thepain in his feet/legs as 9/10 and numbness/paresthesia as 8/10 andburning as a 9/10 bilaterally. Patient rated his numbness and pain bothas “moderate.” Patient reported that his symptoms seemed to increase inseverity at night and prevented him from getting more than 6 hourssleep. The severity of symptoms increased with physical activitiesincluding weight bearing. Patient noted that his balance andcoordination seemed to have worsened over the past year and have been,“iffy lately.”

Treatment History: Patient has seen a neurologist and stated that he hashad an EMG done.

Imaging/Diagnostic studies: EMG positive for peripheral neuropathy

Medications: Thyroxin

Work: Patient is retired

Exercise and Activities: Patient’s exercise and activities were limiteddue to his lower extremity symptoms.

Past Medical and Surgical History: Patient reports hypothyroid Dx whichis being maintained with medication.

Physical Exam: A physical exam was performed and distal pulses werepalpable bilaterally in the lower extremities. Patient had bilateralpositive Tinel’s Test for nerve compression at the tarsal tunnelsbilaterally. Patient was tested with a 256 Hz tuning fork and had a lossof vibration sensation bilaterally distal to the waist.

Patient was tested with a Wartenberg pinwheel and had a hyperesthesia topinprick sensation distal to the knee on the left, and hyperesthesiadistal to the tibial tuberosity on the right.

Bilateral loss of joint motion was noted at the navicular, cuboid, andthe 1-5 metatarsal heads.

Diagnosis: Bilateral lower extremity peripheral neuropathy; Bilateralankle joint dysfunction.

Treatment Plan: Traction manipulation of foot/ankle joints were used torestore motion and decrease irritation to surrounding tissues. Lasertherapy using a class IV laser at 970 nm wavelength was used to decreasepain and enhance treatment process and aid in restoration of function.All treatments were 6 minutes total in the lumbar nerve roots (3 minutesper side) and 12 minutes per lower extremity.

Visit Day Power Root Time (min) Power Extremity Time L/R (min) PhaseCooling Re-Exam 1st 0 6.5 W 6 5.5 W 12/12 1 post 2nd 5 7.5 W 6 6.5 W12/12 1 post 3rd 7 7.5 W 6 6.75 W 12/12 1 post yes 4th 12 7.5 W 6 7 W12/12 4 post 5th 14 7.5 w 6 7.5 W 12/12 4 post 6th 19 7.5 W 6 7.5 W12/12 4 post 7th 21 7.5 W 6 7.5 W 12/12 5 post 8th 26 7.5 W 6 7.5 W12/12 5 post yes 9th 28 7.5 W 6 7.5 W 12/12 6 post 10th 33 7.5 W 6 7.5 W12/12 6 post 11th 35 7.5 W 6 7.5 W 12/12 6 post 12th 40 7.5 W 6 7.5 W12/12 6 post yes 13th 42 7.5 W 6 7.5 W 16/8 7 post 14th 47 7.5 W 6 7.5 W16/8 7 post 15th 52 7.5 W 6 7.5 W 16/8 7 post yes

Re-examination on visit 3:

Tinel’s Test was positive for compression bilaterally at the tarsaltunnels. Vibration sense of the lower extremities was tested with a 256Hz tuning fork. Patient had a loss of vibration sensation distal to theproximal ¼ leg on the right and absent distal to proximal ⅓ leg on theleft.

Patient was tested with a Wartenberg pinwheel and had a bilateralhyperesthesia distal to distal ⅓ legs.

Loss of motion bilateral cuboid and 1-5 metatarsal heads noted.

Patient rated the pain in his feet 5/10, numbness 4/10 and burning nowpresent just in the toes as 3/10. Patient seemed to be makingsatisfactory progress as far as his neuropathic symptoms are concerned.Patient overall notes in general, a significant overall decrease in hissymptoms.

Re-examination on visit 8:

Tinel’s Test was positive bilaterally at the tarsal tunnels. Vibrationsense of the lower extremities was tested with a 256 Hz tuning fork.Patient had vibration sensation now absent only distal to ½ foot on theleft, and absent only distal to the MTP joints on the right.

Patient was tested with a Wartenberg pinwheel and all pinprick sensationwas present. Patient reported having hyperesthesia distal ½ feetbilaterally.

Loss of motion bilateral cuboid and 1-5 metatarsal heads noted.

Patient rated the pain in his feet 5/10, numbness 5/10 and burning at3/10 bilaterally.

Re-examination visit 12:

Tinel’s Test was positive bilaterally at the tarsal tunnels. Vibrationsense of the lower extremities was tested with a 256 Hz tuning fork.Patient had vibration sensation now absent bilaterally plantar forefeet.

Patient was tested with a Wartenberg pinwheel and all pinprick sensationwas present with no hyperesthesia on the right. Patient reported ahyperesthesia to pinprick sensation distal to the MTP joints on theleft.

Patient rated the pain in his feet 4/10, numbness at 2/10 and burning1/10 bilaterally. Symptoms now only present in the distal ¼ feet.

Re-examination visit 15:

Tinel’s Test was positive bilaterally at the tarsal tunnels. Vibrationsense of the lower extremities was tested with a 256 Hz tuning fork.Patient reported vibration sensation hypoesthetic distal balls of thefeet bilaterally.

Patient was tested with a Wartenberg pinwheel and all pinprick sensationwas present with hyperesthesia bilaterally.

Patient rated the pain in his feet 2/10, numbness at 2/10 and burning2/10 bilaterally. Symptoms now only present in the distal, plantar ¼feet.

Results for Patient 1 are shown in the table of FIG. 19 , and agraphical representation of such results is shown in FIG. 20 .

PATIENT 2 Case Study

Chief Complaint: Patient is a 65 year old female; complained ofbilateral numbness/paresthesia, shooting pains, pins and needles andsensitivity distal to the distal ⅓ legs bilaterally. Patient alsocomplained of bilateral distal hand/finger paresthesia as well.

Cause of Neuropathy: Diabetes

Progression of symptoms and present symptoms: Patient stated she becameaware of the symptoms approximately 2 years ago. Patient report thesymptoms started in the toes and severity and surface areas of symptomsseems to be increasing over time. Patient is currently symptomaticbilaterally distal to the distal 1/3 legs bilaterally. Patient reportedher balance has gotten worse over time, and had to consciously be morecareful as she walked. She notes paresthesia in the fingers bilaterally.Patient rated her numbness/paresthesia as 6/10, pain at 9/10 and burningat 4/10 bilaterally.

Treatment History: Patient had seen a neurologist and had a Needle EMGwhich was positive for peripheral nerve dysfunction. Patient had beenprescribed Gabapentin which she reports helps her to sleep.

Imaging/Diagnostic studies: Patient reported having a NCV study whichwas positive for peripheral nerve dysfunction.

Medications: Patient taking Gabapentin for her lower extremitycomplaints

Allergies: Patient denies.

Exercise and Activities: Patient’s exercise and activities were limiteddue to her lower extremity symptoms.

Past Medical and Surgical History: Pt. diagnosed with Type 2 Diabetesapprox. 2 years ago.

Physical Exam: A physical exam was performed and distal pulses werepalpable bilaterally in the lower extremities. Patient had bilateralnegative Tinel’s Test for nerve compression at the tarsal tunnelsbilaterally. Patient was tested with a 256 Hz tuning fork and had a lossof vibration sense distal to the knee on the right and absent distal tothe proximal 1/5 leg on the left.

Patient was tested with a Wartenberg pinwheel and has a loss of pinpricksensation distal to the proximal ¼ leg on the right with hyperesthesiafrom the knee to the proximal ¼ leg on the right. Patient had a loss ofpinprick sensation distal to the proximal ¼ thigh on the left

Patient’s feet/metatarsal areas were not overly sensitive to compression(+Jump); reflexes were 2/4 at the knees bilaterally, and 0/4 bilaterallyat the Achilles with no beats of clonus.

Babinski sign for was negative bilaterally. Bilateral loss of jointmotion was noted at the lunate, navicular, cuboid, and the 1-5metatarsal heads. L4-S1 motor function appeared grossly intactbilaterally.

Diagnosis: Bilateral lower extremity peripheral neuropathy; Bilateralankle joint dysfunction.

Treatment Plan: Traction manipulation of foot/ankle joints to restoremotion and decrease irritation to surrounding tissues. Laser therapyusing a class IV laser at 970 nm wavelength was used to decrease painand enhance treatment process and aid in restoration of function. Alltreatments were 6 minutes total in the lumbar nerve roots (3 minutes perside) and 12 minutes per lower extremity.

Visit Day Power Root Time (min) Power Extremity Time L/R (min) PhaseCooling Re-Exam 1st 0 6.5 W 6 5.5 W 12/12 1 during & post 2nd 5 6 W 6 5W 12/12 1 during & post 3rd 7 6 W 6 5 W 12/12 2 Post yes 4th 12 6.25 W 65.25 W 12/12 4 post 5th 14 3 w 6 2 W 12/12 4 post 6th 19 3.25 W 6 2.25 W12/12 4 post 7th 21 3.75 W 6 2.75 W 12/12 4 post 8th 26 3.75 W 6 2.75 W12/12 4 post yes 9th 28 3.75 W 6 2.75 W 12/12 6 during & post 10th 33 4W 6 3 W 12/12 6 during & post 11th 35 4 W 6 3 W 12/12 6 during & post12th 40 4.25 W 6 3.25 W 12/12 6 during & post yes 13th 42 4.25 W 6 3.25W 12/12 6 during & post 14th 47 4.25 W 6 3.25 W 12/12 6 post 15th 494.25 W 6 3.25 W 12/12 6 post yes 16th 62 4.25 W 6 3.25 W 12/12 6 noneyes 17th 132 4.25 W 6 3.25 W 12/12 7 none yes

Re-examination on visit 3:

Tinel’s Test was negative for compression bilaterally at the tarsaltunnels. Vibration sense of the lower extremities was tested with a 256Hz tuning fork. Vibration sense was now present to distal ⅓ leg on rightand now present to distal ¼ leg on left.

Patient was tested with a Wartenberg pinwheel and has a loss of pinpricksensation distal to ½ foot with hyperesthesia to pinprick ankle to ½foot on the right. Patient reported loss of pinprick sensation distal tothe ankle with a hyperesthesia from distal ¼ leg to ankle on the left.

Patient self-rated symptoms were pain in the lower extremities at 4/10,numbness at 4/10 and burning at 4/10 with a smaller surface area ofsymptoms, but still noticeable in the distal lower extremities.

Bilateral loss of joint motion was noted at the 1-5 th metatarsal heads

Patient reports improvement in perception of vibration sense as well assome reduction in her symptoms. At this point the initial goal ofdetermining if she would respond has been met.

Re-examination on visit 8:

Vibration sense of the lower extremities was tested with a 256 Hz tuningfork. Vibration sense now present to ½ feet bilaterally.

Patient’s distal extremities were tested with a Wartenberg pinwheel,patient reported loss of pinprick sensation bilaterally distal to ½feet. Patient noted a hyperesthesia from ½ foot to the ankle on theleft.

Bilateral loss of joint motion was noted at the navicular, cuboids, andthe 1-5th metatarsal heads

Patient self-rated symptoms were pain in the lower extremities at 4/10,numbness at 4/10 and burning at 4/10

Patient reported she has been having some minor bilateral cramping inthe feet today. Recommended continued stretching at home.

Patient overall noted in general a significant overall decrease in hersymptoms.

Re-examination on visit 12:

Vibration sense of the lower extremities was tested with a 256 Hz tuningfork. Vibration sense now bilaterally absent only distal to the MTPjoints. Patient’s distal extremities were tested with a Wartenbergpinwheel, patient a loss of pinprick sensation only distal to the MTPjoints bilaterally with no reported hyperesthesia.

Bilateral loss of joint motion was noted at the 1-5 th metatarsal heads

Patient self-rated symptoms were pain in the lower extremities at 2/10,numbness at 2/10 and burning at 2/10 with symptoms most noticeable nowin the distal plantar forefeet. Patient overall noted in general asignificant overall decrease in her symptoms.

Re-examination on visit 15:

Vibration sense of the lower extremities was tested with a 256 Hz tuningfork. Vibration sense now present on the right and absent only on theball of the foot on the left.. Patient’s distal extremities were testedwith a Wartenberg pinwheel. Patient noted pinprick sensation now presentand without hyperesthesia on the right. Patient noted a loss of pinpricksensation in the dorsal toes with hyperesthesia ½ foot to MTP joints onthe left.

Bilateral loss of joint motion was noted at the 1-5 th metatarsal heads

Patient self-rated symptoms were pain in the lower extremities at 2/10,numbness at 2/10 and burning at 2/10 with symptoms most noticeable nowin the distal plantar forefeet. Patient overall noted in general asignificant overall decrease in her symptoms.

Re-examination on visit 16:

Vibration sense of the lower extremities was tested with a 256 Hz tuningfork. Vibration sense now present bilaterally.

Patient’s distal extremities were tested with a Wartenberg pinwheel.Patient noted pinprick sensation present on the right. Patient noted asmall area of hyperesthesia on the left in the distal 1 st toe

Bilateral loss of joint motion was noted at the 1-5 th metatarsal heads

Patient self-rated symptoms were pain in the lower extremities at 1/10,numbness at 1/10 and burning at 1/10 with symptoms most noticeable nowin the distal plantar forefeet. Patient notes that her only noticeablesymptom is a stiff sensation in the distal forefeet.

Results for Patient 2 are shown in the table of FIG. 19 , and agraphical representation of such results is shown in FIG. 21 .

PATIENT 3 Case Study

Chief Complaint: Patient is a 62 year old male; complaints of bilateralnumbness/paresthesia, pain, shooting pains, hot burning, tingling/pinsand needles. Patient notes some intermittent balance issues. Patient’ssymptoms were distal to hips bilaterally

Cause of Neuropathy: Unknown.

Progression of symptoms and present symptoms: Patient stated he becameaware of the symptoms approximately 5 years ago. Patient reported thesymptoms started in the toes and progressed proximally and severity ofsymptoms has increased over time. Patient notes that balance hasdecreased over the years and he must be more careful when walking.Patient was symptomatic bilaterally distal to the hips. Patient ratedthe pain his feet/legs as 9/10, numbness/paresthesia as 10/10 andburning as 9/10 bilaterally. Patient reported that his symptoms do notseem to increase in severity at night although they can increase withweight bearing activities.

Treatment History: Patient had seen a Neurologist and had an EMG of hislower extremities.

Imaging/Diagnostic studies: EMG positive for peripheral neuropathy

Medications: Patient was taking Gabapentin 600 mg, Doxazosin 8 mg andzolpidem 10 mg as well as a multi vitamin

Exercise and Activities: Patient’s exercise and activities were limiteddue to his lower extremity symptoms.

Past Medical and Surgical History: Headaches, high blood pressure,depression, back pain, tinnitus, fatigue indigestion, arthritis,irregular sleep and gout.

Physical Exam: Distal pulses were palpable bilaterally in the lowerextremities. Patient had negative Tinel’s Test for nerve compression atthe tarsal tunnels bilaterally. Patient was tested with a 256 Hz tuningfork and had a loss of vibration sensation distal to the kneesbilaterally.

Patient was tested with a Wartenberg pinwheel and had a loss of pinpricksensation distal to the proximal ¼ legs bilaterally with a hyperesthesiato pinprick sensation from the knees to the proximal ¼ legs.

Diagnosis: Bilateral lower extremity peripheral neuropathy; Bilateralankle joint dysfunction.

Treatment Plan: Traction manipulation of foot/ankle joints to restoremotion and decrease irritation to surrounding tissues. Laser therapyusing a class IV laser at 970 nm wavelength was used to decrease painand enhance treatment process and aid in restoration of function. Alltreatments were 6 minutes total in the lumbar nerve roots (3 minutes perside).

Visit Day Power Root Time (min) C/L Power Lower Extremity Time L/R (min)Power Upper Extremity Time L/R (min) Phase U/L Cooling Re-Exam 1st 0 6.5W 0/6 5.5 W 12/12 na na na/4 during & post 2nd 2 7.5 W 0/6 6.5 W 12/12na na na/4 post 3rd 7 7.5 W 2/6 6.75 W 8/8 6.5 W 3/3 ⅗ post yes 4th 97.5 W 2/6 6.75 W 8/8 6.75 W 3/3 ⅗ post 5th 15 7.5 W 2/6 6.75 W 8/8 6.75W 3/3 ⅘ post 6th 45 7.5 W 2/6 6.75 W 8/8 6.75 W 3/3 ⅘ none 7th 51 7.5 W2/6 6.5 W 8/8 6.5 W 3/3 ⅘ none yes 8th 53 7 W 2/6 6 W 8/8 6 W 3/3 ⅘ noneyes 9th 58 7.5 W 2/6 6.5 W 8/8 6.5 W 3/3 ⅘ none 10th 60 7.5 W 2/6 6.75 W8/8 6.75 W 3/3 4/6 post 11th 72 7.5 W 2/6 7.5 W 8/8 7.5 W 3/3 4/6 post12th 74 6 W 2/6 5 W 8/8 5 W 3/3 4/6 post 13th 79 6 W 2/6 5 W 8/8 5 W 3/34/6 post 14th 81 6.25 W 2/6 5.25 W 8/8 5.25 W 3/3 4/7 none 15th 86 6.75W 0/6 5.75 W 12/12 na 0/0 4/7 none yes

Re-examination on visit 3:

Tinel’s Test was negative for compression bilaterally at the tarsaltunnels and fibular heads. Vibration sense of the lower extremities wastested with a 256 Hz tuning fork. Vibration sense was absent distal todistal ⅓ legs bilaterally.

Patient was tested with a Wartenberg pinwheel and had a loss of pinpricksensation distal to ½ leg on the right. Patient reported a loss ofpinprick sensation distal to distal ⅓ leg on the left, withhyperesthesia ½ leg to distal ⅓ leg on the left.

Loss of motion bilateral navicular, cuboid and 1-5 metatarsal headsnoted.

Patient rated the pain in his feet currently as 9/10, numbness as 9/10and burning in the feet as 9/10 bilaterally. Patient notes that whilethe symptoms are still the most severe in the toes, there is a morenormal sensitivity to touch in the legs.

Re-examination on visit 8:

A re-examination was performed on the positive findings found onprevious examination. Tinel’s Test was negative for compressionbilaterally at the tarsal tunnels and fibular heads. Vibration sense wasabsent distal to the ankles on both right and left feet.

Patient was tested with a Wartenberg pinwheel and had a loss of pinpricksensation distal to ½ feet bilaterally.

Loss of motion bilateral navicular, cuboid and 1-5 metatarsal headsnoted.

Patient now rates the pain in his feet 9/10, numbness in his feet 8/10and his burning at 1/10 bilaterally. Patient notes that he has verylittle pain in his feet other than the heel area. The pain and burningsensations are much diminished since onset of treatment. Pain is nowbilaterally in the plantar heel area and could be plantar fasciitis.

Re-examination on visit 12:

Tinel’s Test was negative for compression bilaterally at the tarsaltunnels and fibular heads. Vibration sense was now absent only in theplantar forefeet bilaterally.

Patient was tested with a Wartenberg pinwheel and had a loss of pinpricksensation at the distal ½ 1 st toes bilaterally

Loss of motion bilateral navicular, cuboid and 1-5 metatarsal headsnoted.

Patient rated the pain in his feet 7-8/10, numbness 5/10 bilaterally andburning 0/10 bilaterally. Patient’s main pain still in the plantar heelarea, relieved with rest and exacerbated with weight bearing. Recommendhe is fitted with orthotics by his Podiatrist. Patient notes that he hasmuch more normal sensitivity to touch, and that his sensation ofnumbness is a “puffy” sensation in the dorsal forefoot.

Re-examination on visit 15:

Tinel’s Test was negative for compression bilaterally at the tarsaltunnels and fibular heads. Vibration sense was now hypoesthetic in theplantar forefoot on the right. Vibration sensation now present in theleft foot.

Patient was tested with a Wartenberg pinwheel and reported presence ofpinprick sensation bilaterally with no hyperesthesia.

Loss of motion bilateral navicular, cuboid and 1-5 metatarsal headsnoted.

Patient rated the pain in his feet 6/10, numbness 7/10 bilaterally andburning 0/10 bilaterally. Patient reports that his pain is in theplantar heel area, relieved with rest and exacerbated with weightbearing. His neuropathy pain/burning seems to have resolved withtreatment. He states that he has had plantar fasciitis in the past.Patient reports that his “numbness” is now only an “odd” sensation inthe balls of his feet.

Results for Patient 3 are shown in the table of FIG. 19 , and agraphical representation of such results is shown in FIG. 22 .

The complete disclosures of the patents, patent documents, andpublications cited herein are incorporated by reference in theirentirety as if each were individually incorporated. Variousmodifications and alterations to this disclosure will become apparent tothose skilled in the art without departing from the scope and spirit ofthis disclosure. It should be understood that this disclosure is notintended to be unduly limited by the illustrative embodiments andexamples set forth herein and that such examples and embodiments arepresented by way of example only with the scope of the disclosureintended to be limited only by the claims set forth herein as follows.

1-67. (canceled)
 68. A method of reducing sensory impairment in asubject’s extremity, the method comprising: exposing selected tissue inproximity to a selected nerve root to photonic energy from a therapeuticlaser apparatus at a power of at least 6.5 Watts; and exposing selectedtissue of an affected extremity in proximity to a nerve extending fromthe selected nerve root to photonic energy from a therapeutic laserapparatus at a power of at least 5.5 Watts.
 69. The method of claim 68,wherein the therapeutic laser is a Class IV therapeutic laser apparatus.70. The method of claim 68, wherein exposing selected tissue inproximity to a selected nerve root to photonic energy from a therapeuticlaser apparatus at a power of at least 6.5 Watts occurs before exposingselected tissue of an affected extremity in proximity to a nerveextending from the selected nerve root to photonic energy from atherapeutic laser apparatus at a power of at least 5.5 Watts.
 71. Themethod of claim 68, wherein exposing selected tissue in proximity to aselected nerve root to photonic energy occurs for at least 1 minute. 72.The method of claim 68, wherein exposing selected tissue in proximity toa selected nerve root to photonic energy occurs for no greater than 10minutes.
 73. The method of claim 68, wherein exposing selected tissue ofan affected extremity in proximity to a nerve extending from theselected nerve root to photonic energy occurs for at least 5 minutes.74. The method of claim 68, wherein exposing selected tissue of anaffected extremity in proximity to a nerve extending from the selectednerve root to photonic energy occurs for no greater than 20 minutes. 75.The method of claim 68, wherein exposure of the selected tissue occursfor a period of time sufficient to deliver a total dosage of at least7000 Joules to the selected tissue.
 76. The method of claim 68, whereinexposure of the selected tissue occurs for a period of time sufficientto deliver a total dosage of at least 9000 Joules to the selectedtissue.
 77. The method of claim 68, wherein the exposing steps occur ina first treatment in a series of treatments occurring over a period ofdays or weeks.
 78. The method of claim 77, wherein the treatments of theseries of treatments following the first treatment comprise exposing theselected tissue in proximity to the selected nerve root to photonicenergy from a therapeutic laser apparatus at a power of at least 6.5Watts.
 79. The method of claim 77, wherein the treatments of the seriesof treatments following the first treatment comprise exposing theselected tissue of an affected extremity in proximity to a nerveextending from the selected nerve root to photonic energy from atherapeutic laser apparatus at a power of at least 5.5 Watts.
 80. Themethod of claim 77, wherein the treatments of the series of treatmentsfollowing the first treatment comprise exposing the selected tissue inproximity to the selected nerve root to photonic energy from atherapeutic laser apparatus at a power of less than 6.5 Watts.
 81. Themethod of claim 77, wherein the treatments of the series of treatmentsfollowing the first treatment comprise exposing the selected tissue ofan affected extremity in proximity to a nerve extending from theselected nerve root to photonic energy from a therapeutic laserapparatus at a power of less than 5.5 Watts.
 82. The method of claim 77,wherein the treatments of the series of treatments following the firsttreatment include exposing selected tissue in proximity to a selectednerve root to photonic energy from a therapeutic laser apparatus. 83.The method of claim 77, wherein the treatments of the series oftreatments following the first treatment include exposing selectedtissue of an affected extremity in proximity to a nerve extending fromthe selected nerve root to photonic energy from a therapeutic laserapparatus.
 84. The method of claim 68, wherein exposing selected tissueoccurs bilaterally.
 85. The method of claim 68, wherein the sensoryimpairment is associated with peripheral neuropathy.
 86. A method ofreducing sensory impairment in a subject’s extremity, the methodcomprising: evaluating the sensory impairment; identifying one or morenerves and nerve roots that are associated with, or suspected of beingassociated with, the sensory impairment; exposing selected tissue inproximity to the one or more nerve roots to photonic energy from atherapeutic laser apparatus at a power of at least 6.5 Watts for atleast 1 minute; and exposing selected tissue of an affected extremity inproximity to the one or more nerves extending from the selected nerveroots to photonic energy from a therapeutic laser apparatus at a powerof at least 5.5 Watts for at least 1 minute; wherein the exposing stepsprovide at least 7000 Joules of total energy to the subject.
 87. Amethod of reducing sensory impairment in a subject’s extremity, themethod comprising: evaluating the sensory impairment; identifying one ormore nerves and nerve roots that are associated with, or suspected ofbeing associated with, the sensory impairment; exposing selected tissuein proximity to the one or more nerve roots to photonic energy from atherapeutic laser apparatus at a power of at least 6.5 Watts for atleast 1 minute; exposing selected tissue of an affected extremity inproximity to the one or more nerves extending from the selected nerveroots to photonic energy from a therapeutic laser apparatus at a powerof at least 5.5 Watts for at least 1 minute, wherein the exposing stepsin a first treatment provide at least 7000 Joules of total energy to thesubject; and repeating the exposing steps in one or more subsequenttreatments until at least one symptom of the sensory impairment isreduced.